Preserving Lean Body Mass During Weight Loss In Elderly Obese Patients With GLP-1 Receptor Agonist Treatment
Phase: PHASE2
Conditions: Obesity, Aging
Sponsor: State University of New York at Buffalo

Cover Page for Protocol with Statistical Plan 
 
Official Title: 
Preserving Lean Body Mass During Weight Loss In Elderly Obese Patients 
With GLP-1 Receptor Agonist Treatment   
NCT number: 
 NCT05302596
Document Type: 
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
11/22/2022 
 

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
 
Page 1 of 44 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ....................................................................................................... 2 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Scientific Endpoints* ............................................................................................... 6 
4.0 
Background* ............................................................................................................ 7 
5.0 
Study Design* .......................................................................................................... 9 
6.0 
Study Intervention/Investigational Agent .............................................................. 10 
7.0 
Local Number of Subjects ..................................................................................... 11 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 11 
9.0 
Vulnerable Populations* ........................................................................................ 13 
10.0 Eligibility Screening* ............................................................................................ 14 
11.0 Recruitment Methods ............................................................................................. 15 
12.0 Procedures Involved*............................................................................................. 17 
13.0 Study Timelines* ................................................................................................... 21 
14.0 Setting .................................................................................................................... 21 
15.0 Community-Based Participatory Research ............................................................ 22 
16.0 Resources and Qualifications ................................................................................. 23 
17.0 Other Approvals ..................................................................................................... 24 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 25 
19.0 Data Management and Analysis* .......................................................................... 26 
20.0 Confidentiality* ..................................................................................................... 27 
A. 
Confidentiality of Study Data ......................................................................... 27 
B. 
Confidentiality of Study Specimens ................................................................ 28 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 29 
22.0 Withdrawal of Subjects* ........................................................................................ 31 
23.0 Risks to Subjects* .................................................................................................. 32 
24.0 Potential Benefits to Subjects* .............................................................................. 34 
25.0 Compensation for Research-Related Injury ........................................................... 35 
26.0 Economic Burden to Subjects ................................................................................ 35 
27.0 Compensation for Participation ............................................................................. 36 
28.0 Consent Process ..................................................................................................... 36 
29.0 Waiver or Alteration of Consent Process ............................................................... 41 
30.0 Process to Document Consent ............................................................................... 41 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 42 
32.0 Banking Data or Specimens for Future Use* ........................................................ 43 
 
 
 

 
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IRB Version: 5/6/19 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been added 
to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 6, 21, 22, 24, 25, 26 and 27 do not apply. 
o For exempt research:  Section 6 may not apply. Section 6.1 will still 
apply if there is a study intervention. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly label 
responses when they differ.  For example: 
Response Example 
Intervention Group:  
Control Group: 
Formatting: 
• Do not remove template instructions or section headings when they do not apply to 
your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the Track 
Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
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IRB Version: 5/6/19 
PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Preserving Lean Body Mass During Weight Loss In Elderly Obese Patients With 
GLP-1 Receptor Agonist Treatment   
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Husam Ghanim, PhD 
1000 Young’s Road, Suite 105 
Williamsville, NY 14221 
ghanim@buffalo.edu 
SECONDARY INVESTIGATORS: 
Paresh Dandona, M.D., Ph.D.  
 
Manav Batra, MD,  
 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: V2 11.22.2022 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
11/22/2022 
Change in team members and inclusion in UB-
PIR listing 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources page 
in Click IRB. 

 
Page 4 of 44 
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Response:  
CTSI Translational Pilot Studies Program Grant  
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: The protocol is funded by CTSI pilot studies grant 
 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB correspondence 
(approval, determination letters) as well as signed consent documents.  This 
documentation should be maintained for 3 years after the study has been closed.   
Response:  
Location: Diabetes Endocrinology Research Center of WNY 
Address: 1000 Youngs Road, Suite 105 Williamsville NY 14221 
Department: Diabetes and Endocrinology 
 
1.0 Study Summary 
       
Study Title 
Preserving Lean Body Mass During Weight Loss In Elderly 
Obese Patients With GLP-1 Receptor Agonist Treatment 
 
Study Design 
Single-center, prospective, controlled, randomized and 
open label study 
 
Primary Objective 
To investigate the effect of the semaglutide addition to 
standard of care weight loss intervention (personalized 
lifestyle and exercise) in elderly obese subjects on body 
weight and body composition as assessed by DEXA 
Secondary Objective(s) 
1. To assess between group differences in gene 
expression related to adipose tissue lipolysis and 
changes in mitochondrial metabolism.  
2. To assess between group differences in muscle strength 
as evaluated by both biceps arm strength and 
quadriceps leg strength.  
3. To assess between group differences in measured and 
patient reported side effects including hypoglycemia, 

 
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gastrointestinal concerns, injection site irritation and 
any physical activity limitations.  
Research 
Intervention(s)/ 
Investigational Agent(s)  
Standard of care weight loss program with or without 
semaglutide weekly s.c. injection for 16 weeks 
IND/IDE #  
N/A 
Study Population 
Elderly obese patients: age: ≥65 years, BMI ≥30 Kg/m2 
AND waist circumference for women: > 80cm and for 
men: > 90cm 
Sample Size 
16 
Study Duration for 
individual participants 
Up to 4 months 
Study Specific 
Abbreviations/ 
Definitions  
GLP-1 Receptor Agonist: GLP-1RA 
DEXA: Dual energy X-ray absorptiometry 
 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
PRIMARY OBJECTIVE 
To investigate the effect of the semaglutide addition to standard of care weight loss 
intervention (personalized lifestyle and exercise) in elderly obese subjects on body 
weight and body composition as assessed by DEXA compared to age and gender 
matched control group on standard of care weight loss intervention only. 
SECONDARY OBJECTIVES 
1. 
To assess between group differences in gene expression related to adipose 
tissue lipolysis and changes in mitochondrial metabolism.  
2. 
To assess between group differences in muscle strength as evaluated by both 
biceps strength and quadriceps leg strength.  
3. 
To assess between group differences in measured and patient reported side 
effects including hypoglycemia, gastrointestinal concerns, injection site irritation 
and any physical activity limitations.  
2.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response:  
We hypothesize that:  
Hypothesis 1: We hypothesize that the addition of semaglutide treatment to the 
standard weight loss intervention will lead to greater weight loss, while, 
importantly, also enhancing the proportion of lean (muscle) mass in comparison to 
standard intervention alone.  

 
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Hypothesis 2: We hypothesize that the addition of semaglutide will be associated 
with a gene expression profile favorable for increased lipolysis. Furthermore, we 
hypothesize semaglutide treatment will be associated with greater energy utilization 
and increased mitochondrial reserve in the adipose tissue relative to standard 
intervention alone. 
Hypothesis 3: We hypothesize that semaglutide treatment added to standard weight 
loss intervention will improve muscle strength relative to standard intervention.  
Hypothesis 4: We hypothesize that semaglutide can be safely added to a standard 
weight loss intervention program in obese elderly patients.  
3.0 Scientific Endpoints* 
 
3.1    Describe the scientific endpoint(s), the main result or occurrence under study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a date.   
Response: 
PRIMARY ENDPOINTS  
1- Body weight:  Change from baseline will be calculated at 8 and 16 weeks 
2- Body composition by DEXA: Change from baseline in total body fat (kg), total 
fat-free mass (kg), lean mass (kg) and bone mass (kg), bone mineral density (BMD) 
and lean body mass to total fat mass ratio will be calculated at weeks 16. 
 
SECONDARY ENDPOINTS: 
1) Adipose tissue metabolism and energy expenditure: Subcutaneous abdominal fat 
biopsies will be collected and assayed for A: RNA expression levels (by RT-PCR) 
of genes related to lipolysis (AGTL and HSL), lipid storage and mobilization 
(PPARs and PGC-1a) and mitochondrial thermogenesis (β-adrenergic receptors, 
CPT-1, UCP-1 and UCP-2). B: freshly collected adipose tissue samples will also 
be processed to assess mitochondrial basal and maximal metabolism as well as 
mitochondrial reserve will be measured using the Seahorse XFP energetic flux 
Analyzer.  
2) Blood samples will be assayed for CBC, CMP, and lipid profile and for serum 
insulin, free fatty acids, glycerol, and lipoprotein lipase concentrations.  
3) Muscle strength: at least 2 measures of muscle strength will be collected: biceps 
and quadriceps muscle strength using MicroFET2 dynamometer. 
4) Patient reported side effects and responses to age-appropriate quality of life 
questionnaire will be used to assess any adverse events and changes to quality of 
life and mobility. 
 

 
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4.0 Background* 
4.1 Provide the scientific or scholarly background, rationale, and significance of 
the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response: Americans are living longer and obesity rate is on the rise. These two trends add 
up to an increase in the number of obese older people (1, 2). Both obesity and aging are 
associated with increased risk of chronic diseases such as type 2 diabetes, hypertension, 
cardiovascular diseases and cancer (3). Obesity is also independently associated with all-
cause mortality (4, 5). Abdominal obesity is also associated with accelerated muscle strength 
decline (6) Therefore weight loss is typically recommended to lower many of these risks. 
However, weight loss in older patients is a more complex issue. Aging process is associated 
with loss of muscle mass and increase in fat mass and increasing the risk of sarcopenia (7). 
Approximately 25% - 33% of all weight lost in older adults during intentional weight loss 
interventions is fat-free mass (lean body mass and bone mass) (8, 9), which further 
contributes to sarcopenia and increases risk for impaired activity, disability, and frailty (10, 
11). Therefore, providers can be discouraged from recommending losing weight in this 
population. On the other hand, existing evidence suggests that intentional weight loss should 
be recommended in older people specifically when obesity-related comorbidities exist, 
including those with functional limitations or metabolic complications such as metabolic 
syndrome, type 2 diabetes, and cardiovascular disease (12, 13). The current therapeutic 
options for weight management in older adults do not generally differ from those offered to 
younger or middle-aged people but personalized regular resistance exercise combined with 
adequate protein intake is usually advised to mitigate the risk of further reductions to lean 
mass (12). Unfortunately, very little is done to emphasize the importance of exercise, and/or 
poor adherence in the elderly lead to poor mitigation of weight loss induced sarcopenia. 
Therefore, weight loss intervention that targets fat mass reduction while preserving lean mass 
is clearly needed in older patients.  
GLP-1RAs are drugs approved for use in type 2 diabetes to manage hyperglycemia. They are 
also known, with semaglutide approved, for inducing weight loss by reducing the appetite 
slowing the release of food from the stomach and increasing feelings of fullness after eating. 
We have previously shown that treatment with liraglutide, a GLP-1 RA, improved glycemic 
control and led to significant weight loss in obese type 1 diabetic patients (14). Our data 
reveal that weight loss was attributable to the loss of total body fat, including visceral fat, 
while there was no change in lean body mass as assessed by dual-energy x-ray 
absorptiometry (DEXA). Additionally, this was associated with increased expression of 
genes involved in lipolysis, lipid oxidation and thermogenesis in the adipose tissue including 
ATGL, CPT-1, PPARα, PPARγ, UCP-2 and Dio-2 (14). Our observations are supported in 
part by basic research suggesting that GLP-1 RA induced weight loss involves central and 
peripheral mechanisms, which increase adipose tissue metabolism and thermogenesis (15, 
16). Additional studies have also demonstrated, albeit with significant variability, a fat mass 
targeted weight loss in response to GLP-1 RA treatment in obesity (17). There has been only 
one previous report in a form of a series of cases that looked at the effect of liraglutide on 
weight loss in elderly obese patients with type 2 diabetes (18). In this study, liraglutide 
treatment was associated with reductions in fat mass and android fat and preserved the 
muscular tropism (18). None of these studies prospectively investigated the effect of these 
drugs on weight loss and body composition in older obese patients. Therefore, GLP-1 RAs 

 
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use to safely combat obesity and preserve muscle mass, and potentially improve muscle 
strength, in older obese patients requires further investigation. 
The basis for hypothesizing that GLP-1RA can improve proportion of lean body mass 
while reducing overall body weight is based in part on our data in obese type 1 
diabetes patients treated with liraglutide (14). The hypothesis is also based on basic 
research in animal models suggesting that GLP-1 RA actions in the brain triggers 
many of its effects on the adipose tissue. GLP-RA administered directly in the brains 
of mice lead to reduced body weight and increased brown adipose tissue (BAT) 
thermogenesis through activation of GLP-1 receptors in the hypothalamus which 
increased activity of sympathetic fibers innervating BAT. This was combined with 
increased expression of genes upregulated by adrenergic signaling and required for 
BAT thermogenesis, including PGC1a and UCP-1 (15) and browning of white 
adipose tissue (16). This data supports an independent effect of GLP-1 RA on 
increasing energy expenditure and thermogenesis in the adipose tissue, which can 
potentially translate to fat mass targeted weight loss.  
Our study will be the first prospective randomized and controlled study to investigate 
the ability of semaglutide (the most potent GLP-1 RA) to induce the desired weight 
loss while preserving lean mass in elderly obese patients and to investigate 
mechanisms involved. This approach capitalizes on basic research concepts and 
supported by human data. 
 
4.2 Include complete citations or references.  
Response:  
1. Arias E, Rostron BL, and Tejada-Vera B. United States life tables, 2005. Natl Vital 
Stat Rep. 2010;58(10):1-132. 
2. Collaboration NCDRF. Worldwide trends in body-mass index, underweight, 
overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-
based measurement studies in 128.9 million children, adolescents, and adults. 
Lancet. 2017;390(10113):2627-42. 
3. Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, and Anis AH. The 
incidence of co-morbidities related to obesity and overweight: a systematic review 
and meta-analysis. BMC Public Health. 2009;9:88. 
4. Calle EE, Thun MJ, Petrelli JM, Rodriguez C, and Heath CW, Jr. Body-mass index 
and mortality in a prospective cohort of U.S. adults. N Engl J Med. 
1999;341(15):1097-105. 
5. Flegal KM, Kit BK, Orpana H, and Graubard BI. Association of all-cause mortality 
with overweight and obesity using standard body mass index categories: a 
systematic review and meta-analysis. JAMA. 2013;309(1):71-82. 
6. de Carvalho DHT, Scholes S, Santos JLF, de Oliveira C, and Alexandre TDS. Does 
Abdominal Obesity Accelerate Muscle Strength Decline in Older Adults? Evidence 

 
Page 9 of 44 
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From the English Longitudinal Study of Ageing. J Gerontol A Biol Sci Med Sci. 
2019;74(7):1105-11. 
7. Roubenoff R. Sarcopenic obesity: the confluence of two epidemics. Obes Res. 
2004;12(6):887-8. 
8. Willoughby D, Hewlings S, and Kalman D. Body Composition Changes in Weight 
Loss: Strategies and Supplementation for Maintaining Lean Body Mass, a Brief 
Review. Nutrients. 2018;10(12). 
9. Beavers KM, Beavers DP, Nesbit BA, Ambrosius WT, Marsh AP, Nicklas BJ, et 
al. Effect of an 18-month physical activity and weight loss intervention on body 
composition in overweight and obese older adults. Obesity (Silver Spring). 
2014;22(2):325-31. 
10. 
Villareal DT, Banks M, Siener C, Sinacore DR, and Klein S. Physical frailty 
and body composition in obese elderly men and women. Obes Res. 
2004;12(6):913-20. 
11. 
Rodriguez-Gomez I, Manas A, Losa-Reyna J, Alegre LM, Rodriguez-Manas 
L, Garcia-Garcia FJ, et al. Relationship between Physical Performance and Frailty 
Syndrome in Older Adults: The Mediating Role of Physical Activity, Sedentary 
Time and Body Composition. Int J Environ Res Public Health. 2020;18(1). 
12. 
Coker RH, and Wolfe RR. Weight Loss Strategies in the Elderly: A Clinical 
Conundrum. Obesity (Silver Spring). 2018;26(1):22-8. 
13. 
McTigue KM, Hess R, and Ziouras J. Obesity in older adults: a systematic 
review of the evidence for diagnosis and treatment. Obesity (Silver Spring). 
2006;14(9):1485-97. 
14. 
Ghanim H, Batra M, Green K, Abuaysheh S, Hejna J, Makdissi A, et al. 
Liraglutide treatment in overweight and obese patients with type 1 diabetes: A 26-
week randomized controlled trial; mechanisms of weight loss. Diabetes Obes 
Metab. 2020;22(10):1742-52. 
15. 
Lockie SH, Heppner KM, Chaudhary N, Chabenne JR, Morgan DA, Veyrat-
Durebex C, et al. Direct control of brown adipose tissue thermogenesis by central 
nervous 
system 
glucagon-like 
peptide-1 
receptor 
signaling. 
Diabetes. 
2012;61(11):2753-62. 
16. 
Beiroa D, Imbernon M, Gallego R, Senra A, Herranz D, Villarroya F, et al. 
GLP-1 agonism stimulates brown adipose tissue thermogenesis and browning 
through hypothalamic AMPK. Diabetes. 2014;63(10):3346-58. 
 
 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  

 
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This will be a single center, prospective, open label, randomized and controlled 
pilot study to investigate the effects of semaglutide addition to a standard weight 
loss intervention program for 16 weeks on body weight and composition, adipose 
tissue metabolism and muscle strength compared to the standard weight loss 
program alone in elderly obese patients.  
6.0 
Study Intervention/Investigational Agent 
6.1  
Describe the study intervention and/or investigational agent (e.g., 
drug, device) that is being evaluated. 
Response:  
- 
Semaglutide, a once-weekly injection GLP-1 RA. Starting dose of 0.25mg 
titrated up to 1mg dose. This dose is approved for type 2 diabetes management 
with higher doses approved for obesity management. Experimental arm 
- 
Standard of Care (SOC) weight loss intervention (personalized lifestyle and 
exercise) administered to both experimental and control group. 
 
6.2 
Drug/Device Handling: If the research involves drugs or 
device, describe your plans to store, handle, and administer those 
drugs or devices so that they will be used only on subjects and be used 
only by authorized investigators. 
• 
If the control of the drugs or devices used in this protocol will be 
accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response:  
The study drug will be stored in locked refrigerator in the research building at 1000 
Youngs Road, Suite 105, Williamsville, NY. The study drugs will be accessible by 
authorized study personnel only (physicians, nurses and laboratory staff) and 
amount of drug dispensed to the patient will be properly documented in the charts.  
 
6.3 If the drug is investigational (has an IND) or the device has an IDE or 
a claim of abbreviated IDE (non-significant risk device), include the 
following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 

 
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Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response:  
According to FDA guidelines, the investigator/sponsor of this research considers 
the use of semaglutide in this research exempt from IND requirement. All 
regulation will be followed according to FDA and IRB. 
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that will 
be reviewed locally. 
Response:  
16 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response:  
We expect to screen 20 to 22 patients 
7.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response:  
Preliminary assessment suggests up to 20 elderly obese patients visit the Diabetes and 
Endocrinology Center and Geriatrics clinics per month. We anticipate that a majority 
(60%, 12) will be eligible and off which 33% (4) will agree to participate in the trial. 
 
8.0 Inclusion and Exclusion Criteria* 
8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
1- Males and females age: ≥65 years 

 
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2- BMI ≥30 Kg/m2 AND waist circumference for women: > 80 cm and for men: > 90 
cm 
3- Stable body weight (no more than ±3 kg change during the 3 months prior to 
screening) 
4- Able to participate in personalized physical activities and dietary instructions. 
5- Participant must be able to read, write, and understand the English language and be 
able to provide written consent. 
 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
1. Current diagnosis of weight changing condition including cancer, 
gastrointestinal conditions or eating disorders 
2. GLP-1R agonists use within last 6 months 
3. Diagnosis of type 1 or 2 diabetes 
4. Impaired cognitive function (VA-St. Louis University Mental Survey (VA-
SLUMS) score ≤ 19) 
5. History of chronic/idiopathic acute pancreatitis 
6. Personal/family history of medullary thyroid carcinoma or multiple endocrine 
neoplasia syndrome type 2 
7. Previous surgical treatment for obesity  
8. Smoking or use of any nicotine products 
9. Use of any medication that could interfere with trial results especially weight 
management drugs 
10. Anticipated change in lifestyle (e.g., dietary, exercise or sleeping pattern) other 
than provided by the study. 
11. Hepatic disease or cirrhosis 
12. Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN) and/or 
Alanine aminotransferase (ALT) > 3X ULN 
13. Inability to give informed consent  
14. History of gastroparesis  
15. History of serious hypersensitivity reaction to these agents  
16. Alcoholism  
17. Patients with retinopathy 
18. Participation in any other concurrent interventional clinical trial 
 
8.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:  NA 

 
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☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
8.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection of 
subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who may 
not speak English, the researcher is required to make efforts to recruit and 
include non-English speaking individuals.  However, there are studies in 
which it would be reasonable to limit subjects to those who speak English.  
Some examples include pilot studies, small unfunded studies with validated 
instruments not available in other languages, studies with numerous 
questionnaires, and some non-therapeutic studies which offer no direct 
benefit. 
Response:  
We will not have non-English speaking individuals in this study. We have patients 
that English is a second language, but they can read, write and understand it.  This 
population is less than 10% of the total population. 
 
9.0 Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, however, 
need to provide these checklists to the IRB. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
We will not be using subjects from vulnerable populations  
☒ 
N/A:  This research does not involve pregnant women. 
 

 
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9.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
☒ 
N/A:  This research does not involve prisoners. 
9.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
☒ 
N/A:  This research does not involve cognitively impaired adults. 
9.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically disadvantaged 
persons are vulnerable.  Provide information regarding their safeguards and 
protections, including safeguards to eliminate coercion or undue influence. 
Response:  
No specific populations or vulnerable groups will be targeted. All subjects enrolled 
in this study will be of legal adult consenting age with the ability to speak, read and 
interrupt the English language. Subjects will have the ability to speak with the 
research team regarding any questions or concern they have before signing the 
consent. Subjects will be made aware that this study is voluntary, and they are able 
to stop participating at any time they feel uncomfortable. Subjects will not be 
pressured into participating and their clinic standard of care will remain the same if 
they participate or choose not to participate. 
 
10.0 
Eligibility Screening* 
10.1 Describe screening procedures for determining subjects’ eligibility.  Screening 
refers to determining if prospective participants meet inclusion and exclusion 
criteria.  

 
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Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: 
After obtaining partial HIPAA waiver, patient charts will be screened according to 
the study inclusion and exclusion criteria by our trained clinical staff and 
physicians. In addition, the study clinical team will evaluate their clinic patients for 
possible participation in this study according to the inclusion and exclusion criteria 
at the Diabetes and Endocrinology Center of WNY clinics. Physicians will speak to 
them about their interests in participating in research. If the patient agrees, their 
information will be given to the research coordinator to be contacted for further 
evaluation. The research coordinator will contact interested patients and those 
meeting the inclusion and exclusion criteria based on preliminary phone evaluation 
(phone-script attached) will be invited to participate in the study. All personal 
information will be kept confidential and locked in the coordinator office. In 
addition, interested subjects who are informed about the study through the online 
listing or those referred by other physicians will be contacted and evaluated for 
potential participation. 
Prospective participants who pass the phone screening will be scheduled to An in-
person screening visit. At the screening visit, they will be asked to read the consent 
and any questions they may have regarding the protocol will be answered. If the 
subject wants to participate in the study, they will be asked to sign the informed 
consent form and a copy provided for their record. The subject’s medical history 
and current medications will be obtained as well as their blood pressure and vitals. 
A physical examination will also be done. Blood samples (about 25 ml) will be 
taken to evaluate HbA1c, CBC and CMP. Patients daily eating and exercise habits 
will be collected and reviewed for determining lifestyle intervention. Patients 
meeting all the inclusion and exclusion criteria based on all screening tests will be 
enrolled in the study 
☐ 
N/A:  There is no screening as part of this protocol. 
 
11.0 
Recruitment Methods 
☐ 
N/A:  This is a record review only, and subjects will not be recruited.  
NOTE:  If you select this option, please make sure that all records 
review procedures and inclusion/exclusion screening are adequately 
described in other sections. 
11.1 Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. searching 
charts for specific ICD code numbers, Research Participant Groups, posted 
advertisements, etc.). 
Response: 

 
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Participants will be identified by prescreening clinical charts, patient doctor 
interaction at the time of their visits to the Diabetes Endocrinology Center of 
WNY Locations include: 
1. 1020 Youngs Road, Williamsville NY 14221 
2. 705 Maple Road, Williamsville NY 14221 
3. 462 Grider Street, Buffalo NY 14215  
4. 1000 Youngs Road, Suite 105, Williamsville NY 14221 
5- Patients can be also referred by other physicians and providers. 
Participants will also be recruited through researchmatch.org and the study 
will also be listed on UB’s Study Information Portal (SIP) website.  
Patient records will be reviewed at the time of clinical encounter to identify 
potentially eligible individuals. If a participant is identified during clinical 
encounter, physicians will speak to them about their interests in participating in 
research.   
This study will be publicized on the UB Participate in Research (PIR) portal 
(www.research.buffalo.edu/portal/clinicaltrial/) while in the active recruitment 
period. Once study accruals have been met, the study will be removed from the 
portal. A lay title and study description will be included on the portal and have been 
included as an attachment in Click for approval. Once approval is received, the 
study will be populated onto the portal and will receive its own unique hyperlink. 
The UB PIR Portal was determined to be not research involving human subjects 
(see STUDY00006316 for more information). 
 
11.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response:  
Patient charts will be screened according to the study inclusion and exclusion 
criteria by our trained clinical staff and physicians. If the patient qualifies and is of 
consenting age, the physicians will speak to them about their interests in 
participating in research in a private room where no one else can hear the 
conversation. If the patient agrees, their information will be given to the research 
coordinator to be contacted for further evaluation. No personal information will be 
shared without patient’s approval and will not be used for any purpose except for 
this research. All personal information will be kept confidential and locked in the 
coordinator office. 
11.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior to 

 
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taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response:  
No paper, audio or video advertisement will be used. Patients will be identified 
through screening of clinical charts from investigators clinics and through 
researchmatch.org and UB’s SIP website. 
 
12.0 
Procedures Involved* 
12.1 Provide a description of all research procedures or activities being performed 
and when they are performed once a subject is screened and determined to be 
eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail so 
that another investigator could pick up your protocol and replicate the research.  For 
studies that have multiple or complex visits or procedures, consider the addition of a 
schedule of events table in in your response. 
Response: Eligible and qualified patients will be randomized 1:1 (using Excel, 
Microsoft Inc. randomization function) in pairs (8 pairs) matched by age and BMI 
within 5% and by gender to one of two open-label interventions. Priority of enrollment 
will be to match already existing and non-matched pair(s) before starting new ones. 
However, participants will not need to wait until they are matched to be enrolled in 
the study. The two open-label interventions are:  
1- Control group: Standard of care weight loss program that includes lifestyle changes 
and personalized exercise and dietary education. 
2- Semaglutide group: semaglutide (up to 1mg) once weekly injection added to the 
standard of care weight loss program. Semaglutide dose will be started at 0.25 mg 
dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to 
maximum tolerable dose. Patients will be instructed on how to inject themselves with 
the drug and how to increase the dose. At every visit, number of injections taken and 
doses will be collected. Semaglutide dose escalation is faster than recommended in 
the product label and during clinical use but is consistent with our current studies 
approved by FDA. During this faster dose escalation, we will be monitoring the 
subject more extensively (4 weeks and 8 weeks), compared to clinical practice, for 
any side effects including if they experience any GI side effects, and subjects will be 
kept at the maximum tolerable dose up to 1mg/week. 
At the baseline visit, and for all other visits, patients will come fasting (10 -12 hours) 
to the research center. Patients will visit the research center at 4 weeks (safety visit), 
8 weeks and at 16 weeks (final study assessment visit). Blood (about 25 ml), body 
weight and other vitals, adverse events including hypoglycemia (blood sugar <70 
mg/dl) will be collected at all visits. Fat biopsy aspiration, DEXA scans, muscle 
strength measurement and age-appropriate quality of life questionnaire (Quality of 
Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) will be 
performed at 0- and 16-weeks visits.  

 
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All patients will receive instructions at the beginning of the study on weight loss 
nutritional program and appropriate physical activity to be performed for the next 16 
weeks. The program will be based, in-part, on dietary and exercise habits collected at 
screening visit. For the entire duration of the study, participants will maintain a daily 
diary to document food and exercise activities to ensure compliance with lifestyle 
program provided. At the 4- and 8-weeks visits, the daily diary will be reviewed for 
food and exercise activities, and instructions will be provided again to reinforce 
intervention. 
Patients will be provided with glucose meter and glucose strips to measure 
fingerpick blood glucose. For the entire duration of the study, patients will be asked 
to measure their blood sugars at least one time after exercise and to record any 
hypoglycemic events (glucose <70mg/dl) in their diary, Patients will be instructed 
to record any other untoward side effects like nausea, vomiting, changes in appetite 
and other experiences in the diary. Patients will be instructed to call the Diabetes 
Center to speak to a study investigator directly in case of any problem or untoward 
side effects.  
Subject will receive phone calls at 2- and 12-weeks following start of treatment to 
collect any safety data and at 2 weeks after the end of the treatment. The subjects 
will then be discharged from the study. Patients will be instructed to call the 
research center anytime they have a question or side effects. 
Standard of care weight loss program: 
Patients will be instructed to implement dietary and exercise program for the next 16 
weeks and to record their activities on daily food and exercise diary provided. 
1- Energy intake should be reduced by 500–750kcal/day. 
2- Dietary fat should be reduced to 30% of total energy intake maximally.  
3- Meal replacements (if used) will be consumed during breakfast and lunch. 
4- Dinner consisted of conventional food and participants will be encouraged to eat 
fruits and vegetables within their calorie limit.  
5- Participants should ingest 1.0–1.5g of protein/kg/day and spread consumption 
equally throughout the day. A leucine-enriched balanced amino acid supplement 
can be used.  
6- Subjects will be instructed to perform aerobic, muscle-strengthening, flexibility, 
and balance exercises. Minimally, this should include moderate-intensity aerobic 
activity for 30 minutes five days per week or vigorous-intensity aerobic activity 
for 20 minutes three days a week, 10–15 repetitions of 8–10 major muscle group 
strengthening exercises two or more nonconsecutive days each week, 10 minutes 
of flexibility activities at least two days a week, and balance exercises three times 
a week for fall prevention.  
Fat aspiration procedure: 
Subcutaneous fat tissue aspiration will be performed on abdomen at a 10 cm distance 
from the umbilicus under sterile conditions and local anesthesia. 0.5-3 gm tissue will 
be aspirated and cleared from blood and fluids contaminants by centrifugation. The 
upper adipose tissue will be collected into a separate sterile tube, washed twice with 

 
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cold sterile PBS and centrifuged to remove the PBS. Total RNA, nuclear extracts and 
total cell lysates will be prepared from the adipose. 
DEXA scans: Patients will visit an off-site imaging center (Seton Imaging, Amherst, 
NY) for this test.  
12.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
Study Measures (table 1): 
1- Body weight will be measured with calibrated scale available in the research 
center. Patient will be wearing one outer layer of clothing and no shoes. Change 
from baseline will be calculated at 8 and 16 weeks 
2- Body composition by DEXA: DEXA scans will be performed to collect data on 
total body fat (kg), total fat-free mass (kg), lean mass (kg) and bone mass (kg) and 
bone mineral density (BMD). Lean body mass to total fat mass ratio will be 
calculated at every visit. Changes from baseline will be calculated at week 16.  
3- Adipose tissue metabolism and energy expenditure: Subcutaneous abdominal fat 
biopsies will be collected and assayed for A: RNA expression levels (by RT-PCR) 
of genes related to lipolysis (AGTL and HSL), lipid storage and mobilization 
(PPARs and PGC-1a) and mitochondrial thermogenesis (β-adrenergic receptors, 
CPT-1, UCP-1 and UCP-2). B: freshly collected adipose tissue samples will also be 
processed to assess mitochondrial basal and maximal metabolism as well as 
mitochondrial reserve will be measured using the Seahorse XFP energetic flux 
Analyzer. This will be performed at baseline and at 16 weeks. 
4- Blood samples will be assayed for CBC, CMP, and lipid profile and for serum 
insulin, free fatty acids, glycerol, and lipoprotein lipase concentrations. This will be 
performed at baseline and at 8 and 16 weeks. 
5- Muscle strength: Biceps and quadriceps muscle strength will be collected as the 
average of 3 measurements using the MicroFET2 dynamometer. For these 
assessments, participants will be asked to take a seat and either lift an arm or kick a 
leg straight while be restrained by the MicroFet2 device – allowing collection of 
force generated. This will be performed at baseline and at 16 weeks. 
6- Patient reported side effects and responses to age-appropriate quality of life 
questionnaire will be used to assess any adverse events and changes to quality of life 
and mobility and will be compared to baseline. 

 
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Table 1: Study visits and measurements 
12.3 List any instruments or measurement tools used to collect data (e.g. 
questionnaire, interview guide, validated instrument, data collection form).   
 
Include copies of these documents with your submission. 
Response:  
1- Quality of Life Questionnaire 
2- Source Documents will be used to collect data during visits 
3- MicroFET2 dynamometer will be used to measure muscle strength 
4- Daily Diary (to collect food and exercise and other events). 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response:  
Electronic medical records, clinical charts and research files will be accessed using 
HIPAA partial waiver and signed informed consent HIPAA authorization. 
12.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) and 
if so, describe how these will be shared. 
Response:  
Visit #  
 
1 
2 
3 
4 
Week# (±2-7days)  
-4 to 0 0 
4 
8 
16 
Study Procedures  
Screeni
ng  
  
Randomiz
ation/start 
interventi
ons 
  
  
 End of 
Study 
History  
X 
 
 
 
 
Physical  
X 
 
 
 
 
Vitals including body weight 
X 
X 
X 
X 
X 
CBC, CMP 
X 
X 
X 
X 
X 
Dietary and exercise education  
 
X 
X 
X 
 
Study drug titration  
 
X 
X 
 
 
Dispense medications  
 
X 
X 
X 
 
Adverse Event reporting 
 
X 
X 
X 
X 
DEXA imaging 
 
X 
 
 
X 
Research blood endpoints  
 
X 
 
X 
X 
Fat biopsy  
 
X 
 
 
X 
Muscle strength testing  
 
X 
 
 
X 
Quality of life questionnaire 
 
X 
 
 
X 

 
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Individual participant lab results will be disclosed to the participant upon their 
request. If the participant requests documentation be shared with another physician, 
physician office or hospital, the participant must come to the research center to 
collect said documentation and/or the documentation can be mailed to their given 
home address.  
 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response:  
Not Applicable. Study results will not be shared with the subjects. However, 
unidentifiable study results could be published in the form of a manuscript or 
abstract and will be reported to clinicaltrilas.gov. 
 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
up to 4 months 
13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
Up to 5 months 
13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected, and all analyses have been completed). 
Response:  
11 months 
14.0 
Setting 
14.1 Describe all facilities/sites where you will be conducting research procedures.  
Include a description of the security and privacy of the facilities (e.g. locked 
facility, limited access, privacy barriers).  Facility, department, and type of 
room are relevant.  Do not abbreviate facility names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical Center, 
a fully accredited tertiary care institution within New York State with badge access,” 
or, “Community Center meeting hall.” 
Response:  
Research will be conducted at the Diabetes Endocrinology Research Center of 
WNY, located at 1000 Youngs Road, Suite 105, Williamsville NY 14221 and at the 

 
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CTRC located in 875 Ellicott St. Buffalo NY14203, Division of Endocrinology, 
Diabetes and metabolism, Department of Medicine. Both facilities are locked 
facilities with limited access and with security cameras installed outside and inside 
the facilities. Keys or swipe cards are needed to access the facilities. The Diabetes 
Research Center has private exam rooms available for physical exam, fat biopsy 
collection and other rooms needed to conduct procedures needed for the study. 
Study coordinator and registered nurse are available during visits for data collection 
and blood work. One of the investigators will be available during visits to address 
patients’ related issues. CTRC location is a fully equipped laboratory with 
Equipment include ultra-low freezers for sample storage, preparation and analysis 
using ELISA and PCR. All offices were study and patients’ information is stored 
have locked cabinets and password-secured computers for protection of data with 
access limited to study personal 
The VA (3495 Bailey Avenue, Buffalo, NY 14215) location will be utilized to 
conduct mitochondrial basal and maximal metabolism as well as mitochondrial 
reserve using the Seahorse XFP energetic flux Analyzer. The VA Lab facility is 
fully secured with access limited to facility users and research staff. 
14.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside UB, 
i.e. research conducted in the community, school-based research, international 
research, etc.  It is not referring to multi-site research.  UB affiliated institutions 
include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process and 
recognizes the unique strengths that each brings.  CBPR begins with a research topic 
of importance to the community, has the aim of combining knowledge with action and 
achieving social change to improve health outcomes and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 
15.2 
Describe the composition and involvement of a community advisory board. 

 
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Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 Describe the qualifications (e.g., education, training, experience, expertise, or 
certifications) of the Principal Investigator and staff to perform the research.  
When applicable describe their knowledge of the local study sites, culture, 
and society.  Provide enough information to convince the IRB that you have 
qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the qualifications 
described to fulfill their roles. 
Response:  
All study personnel are educated, trained, and licensed as required for their delegated 
role in this study. All study personnel have also received the required university 
training and will be trained by the PI before the study starts. The PIs, CO-
investigators and research team have conducted similar studies in this patient 
population using similar agents and have the expertise to execute the study protocol 
and manage any adverse events. All team members are experts in their fields with 
extensive published records. 
Dr Ghanim (PhD, Biochemistry) will supervise regulatory and IRB filings, overall 
execution of the protocol, sample collection, processing and perform gene 
expression analysis. Dr Ghanim will advise participants on lifestyle changes, 
perform muscle strength tests and perform adipose tissue/mitochondrial respiration 
assays. Dr Ghanim will also perform data and statistical analysis, interpret data and 
write manuscripts. 
Drs Paresh Dandona and Manav Batra (MDs, Endocrinologists) will support clinical 
protocol execution, patients’ management and clinical data related to safety and dose 
escalation of the study Drug. They will also participate in data interpretation and 
manuscript writing. Dr. Batra will also perform fat biopsy collection. In 
collaboration with Dr Ghanim and Troen, they will also provide personalized 
exercise and dietary instructions and education to all patients enrolled in the study at 
baseline and at 8 weeks.  
Jeanne Hejna, (LPN, Research Nurse/coordinator): will be responsible for patient 
consenting, protocol executions, drug dispensing and recording (in consultation with 
Endocrinologists), blood sample collection and maintaining all study documents and 
records. 
Describe other resources available to conduct the research.  

 
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16.2 Describe the time and effort that the Principal Investigator and research staff 
will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours per 
week.  The question will elicit whether there are appropriate resources to conduct the 
research. 
Response:  
The principal investigator supervises the research project and monthly research 
meetings are conducted to discuss the recruitment rate, resolve and discuss issues 
related to the conduct, safety, analysis of samples and discuss study and related 
publications. PI is expected to spend 15% of his academic time on this research. 
The co-investigators and study coordinator provide coverage to the research related 
activity during regular hours. 
16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist for 
a study that screens subjects for depression. 
Response:  
Available medical literature will be provided as deemed appropriate or requested by 
patients through UB libraries, Pubmed, Google scholar as all the investigators have 
access to medical literature through listed resources above 
The patient will also have access to physicians who will be available to address any 
adverse effects or other questions during the course of the study  
 
16.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response:  
Before beginning of enrollment all research staff will be asked to review the 
protocol and a training session will be conducted to provide protocol details, 
explain technical points, and answer staff questions. All training sessions will have 
a sign in sheet to document such training. Continuous education through training 
meetings, conferences and discussions will continue through the study period and 
when revisions are made to protocol. 
17.0 
Other Approvals 
17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 

 
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☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 
18.1 Describe how you will protect subjects’ privacy interests during the course of 
this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include: “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the participant 
is reminded that they are free to refuse to answer any questions that they do not feel 
comfortable answering.”   
Response:  
Our clinical providers involved in the study will identify potential patients for 
recruitment from the Diabetes-Endocrinology Center of WNY Clinics according to 
the inclusions and exclusion criteria. Patient who qualifies will be asked in private 
during their one-on-one consultation time with the physician if they wish to 
participate in the research study. If the patient agrees, the research coordinator will 
contact them privately for a possible telephone screening and ask if time is 
appropriate for this discussion.  
When the patient is being seen at our clinics for the first time they sign the “Consent 
to use and disclosure of protected health information” form which clearly states that 
their protected health information (PHI) can be used for review in preparation for 
possible research. Additionally, a partial HIPAA waiver will be obtained to access 
medical records when screening for patients. 
If the patient passes the telephone screening, they will be asked to make an 
appointment to review and sign the consent. Patient will do this in a private room 
in the research unit and will be allowed to discuss the consent in detail with the 
research coordinator and or study doctor. Patient will be notified that it is 
completely voluntary to participate in the research study and can withdraw at any 
time. 
We will not be accessing any medical information of the patients for whom the 
services are not provided by our clinic providers before partial HIPAA is obtained 
or informed consent is signed. 
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include: school permission for review of 
records, consent of the subject, HIPAA waiver.  This question does apply to records 
reviews. 
Response:  
Consent of the subject and partial HIPAA waiver 

 
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19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
Analytical plan: 
Measurements taken on a continuous scale will be summarized by range, median, 
means and standard deviations. Categorical measurements will be summarized using 
percentages, various types of cross-tabulations, and proper graphical presentations. 
Type-I error will be set to 5%, i.e. α=0.05, for all the statistical tests. Baseline values 
for patients’ demographics and concomitant illnesses will be compared using 
parametric or non-parametric tests. The primary endpoint will be to compare the 
between group differences in lean body mass/total fat mass ratio changes from 
baseline at 16 weeks. Secondary end points will include the additional study measures 
listed above assessed as the difference between groups at 8 and 16 weeks. 
Statistical analysis will be carried out using SPSS and SigmaStat software (SPSS, 
IL). All data will be expressed as mean ± S.E of arbitrary units and percent change 
is calculated from the means for mRNA gene expression. To evaluate similarity 
between the study groups, baseline values for subject’s demographics will be 
compared using appropriate parametric and non-parametric tests based upon the 
nature of the data. 
19.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study objectives 
and justify a conclusion.  
Response:  
There are no previous studies investigating the effect of semaglutide in the age 
group specifically, however semaglutide was shown to induce significant weigh 
loss (about 5%) predominantly from body fat mass in obese subjects. Therefore, 
with an estimated difference between semaglutide group and standard of care only 
group of about 50% in the primary endpoint, a sample size of 8 patients in each 
group (semaglutide vs control) should provide at least 80% power to detect a 
significant difference (α = 0.05), provided the standard deviation of the residuals 
(variability) is not greater than half the estimated difference between the groups. 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
Response:  
Two investigators and study coordinator will double check the accuracy of collected 
data. All laboratory testing will be standardized using references and standards. 

 
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20.0 
Confidentiality* 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data and 
any records that will be reviewed for data collection.   
 
20.1 
A.  Where and how will all data and records be stored?  Include information 
about: password protection, encryption, physical controls, authorization of access, 
and separation of identifiers and data, as applicable.  Include physical (e.g. paper) 
and electronic files. 
Response:  
All data records will be stored on password protected computers and or in locked 
cabinets within the research department and lab. All subject data collected after 
enrollment in study will be stored in a coded format. Documents related to IRB 
correspondences, consent forms and other paper documents with patients’ 
identifiable information, including the master list/code key containing patient 
identifiers, will stored in locked cabinet in a locked office. Additional paper 
documents containing coded patients’ data will be stored in separate binders in a 
different locked cabinet. 
Digital coded data will be stored in password locked computers accessible by study 
team only. 
20.2 
A.  How long will the data be stored? 
Response:  
1. IRB correspondence (approval, determination letters) as well as any 
signed consent documents should be maintained for at least 3 years after the 
study has been closed.   
2. Any master list/code key containing patient identifiers should be deleted 3 
years after the study related analysis has ended.   
3. Working data analysis files that contain no identifiable information will 
be maintained indefinitely. Researchers may continue to use such stored 
data to further develop this research concept  
20.3 
A.  Who will have access to the data? 
Response:  
Those investigators, nurses, and laboratory staff that are on all involved in this 
study and listed on IRB submission will have access to the data. 
 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  

 
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Those physicians, nurses, and laboratory staff that are on all documentation for the 
study will have access to the data and can handle transfer of data. 
 
20.5 
A.  How will the data be transported? 
Response: 
Coded DEXA data from Seton imaging will be emailed to study coordinator and PI. 
All data are stored at study performance sites only and is not transported unless it is 
being archived. At that point files will be transferred to Iron Mountain for storage 
and archiving.  
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.  
 
☐ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 21.0) 
 
20.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
The coded specimens will be stored in the laboratory located at the CTRC located in 
875 Ellicott St. Buffalo NY14203. Samples will be stored in a locked -80o C freezer. 
 
20.7 
B.  How long will the specimens be stored? 
Response:  
Specimen storage has no expiration date and will be stored for a minimum of 7 
years. Researchers may continue to use stored specimens to further develop this 
research concept  
 
20.8 
B.  Who will have access to the specimens? 
Response:  
Those physicians, nurses, and laboratory staff that are on all documentation for the 
study will have access to the specimens 
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 

 
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Response:  
Those physicians, nurses, and laboratory staff that are on all documentation for the 
study will have access to specimens and can handle transfer of samples 
 
20.10 B.  How will the specimens be transported? 
Response: 
 
Samples will be transported by the laboratory technician which will be hand 
delivered using dry ice in a properly labeled Styrofoam container. 
 
 
21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A:  This study is not enrolling subjects or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
The principal investigator and co-investigators will review the data every 3 months 
to assess the safety and potential benefits to the participant. The investigators will 
assess other risks including the physical, psychological, social and economic harm 
to these patients. The investigators will carefully watch for any invasion of privacy 
and breach of confidentiality. 
 
21.2 Describe what data are reviewed, including safety data, untoward events, and 
efficacy data. 
Response:  
Efficacy data: 
1- Body weight:  Change from baseline will be calculated at 8 and 16 weeks 
2- Body composition by DEXA: Change from baseline in total body fat (kg), total 
fat-free mass (kg), lean mass (kg) and bone mass (kg), bone mineral density 
(BMD) and lean body mass to total fat mass ratio will be calculated at weeks 16. 

 
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3- Adipose tissue metabolism and energy expenditure: Subcutaneous abdominal fat 
biopsies will be collected and assayed for A: RNA expression levels (by RT-PCR) 
of genes related to lipolysis (AGTL and HSL), lipid storage and mobilization 
(PPARs and PGC-1a) and mitochondrial thermogenesis (β-adrenergic receptors, 
CPT-1, UCP-1 and UCP-2). B: freshly collected adipose tissue samples will also 
be processed to assess mitochondrial basal and maximal metabolism as well as 
mitochondrial reserve will be measured using the Seahorse XFP energetic flux 
Analyzer.  
4- Muscle strength: at least 2 measurements of muscle strength will be collected: 
Biceps and quadriceps muscle strength using MicroFET2 dynamometer. 
Safety Data: 
1- CBC and CMP data will be reviewed for any untoward outcomes.  
2- Patient reported side effects including hypoglycemia, GI side effects, injection 
site reaction will be used to assess any adverse events  
21.3 Describe any safety endpoints. 
Response:  
1- Hypoglycemia (glucose <70mg/dl) as reported by patients. 
2- Frequency and severity of GI side effects 
3- Mobility related events including, falls, fractures, dizziness, and loss of balance. 
4- injection site reactions 
5- Adipose tissue biopsy site swelling or other complications. 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response:  
Safety event and side effect will be recorded on case report forms during the visit. 
We also encourage participants to call us if they develop any adverse reaction. 
 
21.5 Describe the frequency of safety data collection. 
Response:  
The data collection will be done at all study visits. The patients, however, will be 
asked to report any adverse event or safety related information via phone as soon as 
it occurs.  
21.6 Describe who will review the safety data. 
Response:  
The safety data will be reviewed by the principle and sub investigators as well as 
the research coordinator 
 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 

 
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Response:  
Safety data will be reviewed every three months throughout the duration of the 
study.  
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A- this is a pilot study that may not have enough participant to draw 
statistical conclusions for safety data. 
 
21.9 Describe any conditions that trigger an immediate suspension of the research. 
Response: 
No interim analysis is planned for efficacy so termination of study will be related to 
safety. Significant increases in severe hypoglycemic (glucose<55mg/dl or requiring 
assistance) events or severe side effects related to study drug are possible, although 
not likely, causes that might trigger termination of study. Serious adverse 
reactions/side effects from fat biopsy procedure might trigger revision of protocol to 
eliminate fat biopsy collection. Study can be terminated if IRB or CTSI suspends 
this research 
22.0 
Withdrawal of Subjects* 
☐ 
 N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response:  
- 
Serious adverse GI reactions to semaglutide 
- 
Sever hypoglycemic events 
- 
lack of adherence to weight loss program or lack of compliance to study 
medication. 
 
22.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for physical 
or emotional health. 
Response:  
The PI can stop investigational study treatment or remove participants from the trial 
without participants approval. If a patient participation is terminated or the patient 
withdraws consent and decide not to participate in the study, she/he will be asked to 
undergo a final study visit for his/her safety. Final blood sample collection, DEXA 
scan and fat biopsy procedures may be performed if patient agrees. If a subject 

 
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withdraws from the research, the data collected to that point will be used toward the 
research finding. If applicable the subject will have to bring back any unused 
research drug.  
 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response:  
If a subject withdraws from the research, the data collected to that point will be 
used toward the research finding. 
If necessary, they will be asked to complete an end of study visit for their safety.  
 
23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or inconveniences 
to the subjects related to their participation in the research. Consider 
physical, psychological, social, legal, and economic risks.  Include a 
description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response:  
- 
The risks associated with the study blood draw are generally considered to be 
minimal. All subjects will be informed of the complication of venipuncture, which 
includes mild bruising at the site, which should resolve in few days. They will also 
be informed about the possibility of infiltration at the time of performing blood 
draws in which case another venipuncture at different site will be performed and 
this may lead to bruising at more than one sites. Serious risks associated with 
venipuncture may also include infections and thrombosis. If any of these serious 
side effects is observed, the patients will be asked to call us immediately or seek 
immediate medical help. 
- 
The risks involved with fat biopsy procedure are also very minimal. This procedure 
is performed under local anesthesia and therefore study subjects might experience 
momentary discomfort at the time of giving local anesthesia. There is a small risk of 
bleeding at the site of incision, but this will be controlled with cotton gauzes and 
pressure. The risk of infection is very rare as the procedure is done under sterile 
conditions.  
- 
Potential side effects of GLP-1 RA, like semaglutide, include GI side effects 
including nausea (especially when you start using semaglutide); vomiting, stomach 
pain, loss of appetite; diarrhea; or constipation. 

 
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- 
The risk of hypoglycemia appears to be low with semaglutide, however, it could 
increase when combined with exercise or lower food intake as proposed in this 
study. 
- 
In rodents, semaglutide causes dose-dependent and treatment-duration-dependent 
thyroid C-cell tumors at clinically relevant exposures. However, it received FDA-
approval for the treatment of type 2 diabetes in 2017 following large Phase 3 trials 
including the cardiovascular safety trial SUSTAIN-6. Based on the above rodent 
studies, semaglutide is contraindicated in those with a personal or family history of 
medullary thyroid carcinoma and in patients with Multiple Endocrine Neoplasia 
syndrome type 2 (MEN 2). However, following review of human data with GLP-
1RAs, FDA does not require or suggest routine monitoring of serum calcitonin/ 
thyroid ultrasound in people treated with semaglutide.  
- 
Injection-site reactions: Serious injection-site reactions, with or without bumps 
(nodules), have happened in some people who use GLP-1RAs but are less frequent 
with semaglutide. Injection-site reactions have rarely required surgical intervention. 
Participants will be instructed to report any injection site reactions including nodules 
to study investigators.  
- 
Kidney injury: GLP-1 RA might cause acute kidney injury in patients without 
underlying renal disease especially in patient who had experienced nausea, 
vomiting, diarrhea or dehydration.  
- 
Severe allergic reaction (anaphylaxis) to study drug ingredients may accrue in rare 
cases.  
- 
There might be other unforeseen risks associated with the use of semaglutide in this 
age population. 
- 
Exercise related events including, falls, fractures, dizziness, and loss of balance.  
- 
Patients always run a risk of breach of confidentiality when doing a research trial. 
However, procedures are in place to minimize this risk as described in the protocol 
and consent. 
 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response:  
- We will collect no more than 25 ml of blood on each study visit. We will follow 
standard sterilization procedures. Safety data will be collected at screening and 
during the study.  
- To lessen risk of hypoglycemia, patients will be instructed to not exercise before 
mealtime and up to 1hr after meals. For the entire duration of the study, patients 
will be asked to measure their blood sugars at least one time daily after exercise. 
Patients will maintain a diary to record any hypoglycemia and other untoward side 
effects like nausea, changes in appetite and other experiences. Patients will be 
instructed to consume a small sugary drink or small, sweet snack if blood sugar is 

 
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>70mg/dl and to repeat the test in 30 min. They will be also instructed to call the 
Diabetes Center to speak to a study investigator directly in case of any problem or 
untoward side effects. They will be specifically asked to call if they have 
hypoglycemia (blood sugar <70 mg/dl) on more than one occasion.  
- Injection site reactions and complications from fat biopsy collection will be 
monitored. If injection site reaction is observed or reported patient will be instructed 
to alternate semaglutide injection site.  
- Risk of acute kidney injury or renal function impairment: CBC, CMP, including 
kidney function test will be performed at screening and every visit of the study 
(table 1). Additional testing will be performed in patients who suffer from sever 
nausea or GI symptoms or hypovolemia. 
- To reduce the risk of injury due to exercise patients will be instructed to perform 
warm up and cool down stretching exercises. Subjects will also be advised to stop 
exercise in the event of unexpected pain, dizziness or discomfort and to contact the 
study team. 
Research team will monitor patients for side effects and other unwanted outcomes 
through phone calls, patients own reporting and during visits. 
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: Any adverse effects of semaglutide not currently known may be some of 
the unforeseeable risks. 
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
NA, this study is not recruiting women of childbearing age. 
 
23.5 If applicable, describe risks to others who are not subjects. 
Response:  
NA 
24.0 
Potential Benefits to Subjects* 
24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and duration 
of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response:  

 
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While following a weight loss dietary and exercise program with or without study 
drug can lead to weight loss, the short duration of the intervention may reduce the 
magnitude of such benefit. Participants in this study may not directly benefit from 
the biomarker assessments and the results will not be reported in their clinical 
record. 
 
25.0 
Compensation for Research-Related Injury 
☐ 
N/A:  The research procedures for this study do not present risk of research 
related injury (e.g. survey studies, records review studies).  This section 
does not apply.   
25.1 
If the research procedures carry a risk of research related injury, describe 
the available compensation to subjects in the event that such injury should 
occur.   
Response: 
Routinely, Buffalo General Hospital, Erie County Medical Center, and/or the 
University at Buffalo, State University of New York, its agents, or its employees do 
not compensate for or provide free medical care for human subjects/participants in 
the event that any injury results from participation in a human research project.  In 
the unlikely event that they become ill or injured as a direct result of participating in 
this study, they may receive medical care that will be billed to their insurance, paid 
by patient or 3rd paying party. 
 
25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the current 
version here.  If the contract is later approved with different language regarding 
research related injury, you must modify your response here and submit an 
amendment to the IRB for review and approval. 
Response:  
NA 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
All research expenses during visits will be covered by research funds. Cost of 
adherence to weight loss program (dietary and exercise needs) is the responsibility 
of the participants.  

 
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☐ 
N/A:  This study is not enrolling subjects or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, including 
monetary, course credit, or gift card compensation. 
Response:  
• 
Screen: $0 
• 
Visit 1: blood draw ($25), fat biopsy ($75), DEXA ($25) 
•       Visit 2: blood draw ($25) 
•  
Visit 3: blood draw ($25)  
•       Visit 4: blood draw ($25), fat biopsy ($75), DEXA ($25) 
• 
Completed daily diary: $50/study (prorated if not fully completed) 
 
*Total compensation for all completed visits: $    350.00  
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☐ 
N/A:  There is no compensation for participation.  This section does 
not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will be 
obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 29.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 29.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
All participants will come to the research department at Diabetes and 
Endocrinology research to be consented. Participants will be placed in a private 
room where they can review the consent. Participant questions and or concerns will 
be address with a member of the study team or research doctor if applicable. The 
research coordinator will discuss in length the participant’s requests for privacy of 
their PHI 
 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   

 
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NOTE:  It is always a requirement that a prospective subject is given sufficient time 
to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response:  
Participants will be made aware that participating in research is completely 
voluntary, and they may withdraw at any time with no consequence to their routine 
clinic care. If the patients require time to decide and or discuss partaking in a 
research study, the subject will be given said time.  
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  
The research coordinator and study team are available to answer any question or 
concerns with the patient during the duration of the research trial. At each study 
visit, the patient is asked a series of questions to ensure they are on task with the 
study visits and feel comfortable. Upon departing from their study visit, the patients 
are told of their next visit and given detail instruction for their next visit. If study is 
revised or amendment or new information becomes that may affect patients’ 
participation, the patient may be re-consented to ensure patient ongoing consent. 
 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. If not, or 
if there are any exceptions or additional details to what is covered in the SOP, 
describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or undue 
influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English-speaking subjects.   
(Skip to Section 28.8) 
28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 

 
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NOTE: The response to this Section should correspond with your response to Section 
8.4 of this protocol. 
Response:  
NA 
28.7 If subjects who do not speak English will be enrolled, describe the process to 
ensure that the oral and written information provided to those subjects will be 
in that language, how you will ensure that subjects are provided with a 
sufficient period of time to consider taking part in the research study, and any 
process to ensure ongoing consent. Indicate the language that will be used by 
those obtaining consent.  
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
NA 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 28.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response: In addition to reviewing medical records for any diagnosis of impaired 
cognitive function, the study team will evaluate participants responses during the 
screening process as an indicator of their cognitive function. 
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 28.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 28.9 and 
28.10) and, where possible, assent of the individual should also be solicited 
(Sections 28.11 and 28.12). 
28.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic medical 
record to determine if an LAR is recorded. 

 
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Response:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information that 
describes which individuals are authorized under applicable law to consent 
on behalf of a prospective subject to their participation in the research. One 
method of obtaining this information is to have a legal counsel or authority 
review your protocol along with the definition of “legally authorized 
representative” in “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013).” 
Response:  
This research will not be conducted outside the state of NY 
 
28.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent and 
which will not. 
Response:  
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 29.0) 
28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 

 
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procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)” to be 
aware of which individuals in the state meet the definition of “children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
 
28.14For research conducted outside of New York State, provide information that 
describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review your 
protocol along the definition of “children” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
NA 
28.15 Describe whether parental permission will be obtained from: 
Response:  
NA 
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the 
care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe your 
procedure for determining an individual’s authority to consent to the child’s 
general medical care. 
Response:  
NA 

 
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28.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response:  
NA 
28.18 When assent of children is obtained, describe how it will be documented. 
Response:  
NA 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent for 
Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any additional 
information necessary here: 
Response:  
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 31.0) 
30.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes referred 

 
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to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written Documentation of 
Consent (HRP-411)” to ensure that you have provided sufficient information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-502)”.  
If you will obtain consent, but not document consent in writing, attach the script of 
the information to be provided orally or in writing (i.e. consent script or Information 
Sheet).   
Response:  
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following. See 
“WORKSHEET: Communication and Responsibilities (HRP-830).”: 
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the modification 
is implemented. 
• 
All engaged participating sites will safeguard data as required by local 
information security policies. 
• 
All local site investigators conduct the study appropriately in 
accordance with applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
31.3 Describe the method for communicating to engaged participating sites (see 
“WORKSHEET: Communication and Responsibilities (HRP-830)”): 

 
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• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Response:  
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 
• 
Where and how data or specimens will be stored locally? 
• 
How long the data or specimens will be stored locally? 
• 
Who will have access to the data or specimens locally? 
• 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
• 
How data and specimens will be transported locally? 
Response:  
 
31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.  Local recruitment methods are 
described elsewhere in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 
• 
Describe the methods that will be used to identify potential 
subjects. 
• 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response:  
 
32.0 
Banking Data or Specimens for Future Use* 
☐ 
N/A:  This study is not banking data or specimens for future use or research 
outside the scope of the present protocol.  This section does not apply. 
32.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 

 
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data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template Consent 
Document (HRP-502). 
Response:  
The study data/specimens will be stored in a locked closet in Diabetes 
Research center or in -80 freezers at the research laboratory (875 Ellicott St, 
CTRC) for at least 7 years 
The research staff (study personnel including coordinator) only will be 
authorized to access data and or specimens. Data and specimens might be 
used in future assessments related to the advancement of this research 
subject. 
 
32.2 List the data to be stored or associated with each specimen. 
Response:  
Patient ID number, study visit information and date of collection will be stored with 
specimen. Other data stored will include record files of all patients participating in 
the study, including data collection sheets and lab results. 
 
32.3 Describe the procedures to release banked data or specimens for future uses, 
including: the process to request a release, approvals required for release, 
who can obtain data or specimens, and the data to be provided with 
specimens. 
Response:  
No data or specimens will be released to any party outside research team.