Comparison of Effects of Simvastatin Versus Ezetimibe on Intracellular Lipid and Inflammation in Obese Subjects
Phase: PHASE4
Conditions: Inflammation, Atherosclerosis, Hypercholesterolemia
Sponsor: paresh Dandona

 
 
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Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ....................................................................................................... 2 
1.0 
Study Summary ........................................................................................................ 5 
2.0 
Objectives* .............................................................................................................. 6 
3.0 
Scientific Endpoints* ............................................................................................... 6 
4.0 
Background* ............................................................................................................ 7 
5.0 
Study Design* ........................................................................................................ 11 
6.0 
Study Intervention/Investigational Agent .............................................................. 12 
7.0 
Local Number of Subjects ..................................................................................... 13 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 13 
9.0 
Vulnerable Populations* ........................................................................................ 15 
10.0 Eligibility Screening* ............................................................................................ 16 
11.0 Recruitment Methods ............................................................................................. 17 
12.0 Procedures Involved*............................................................................................. 18 
13.0 Study Timelines* ................................................................................................... 22 
14.0 Setting .................................................................................................................... 23 
15.0 Community-Based Participatory Research ............................................................ 24 
16.0 Resources and Qualifications ................................................................................. 24 
17.0 Other Approvals ..................................................................................................... 26 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 26 
19.0 Data Management and Analysis* .......................................................................... 27 
20.0 Confidentiality* ..................................................................................................... 28 
A. 
Confidentiality of Study Data ......................................................................... 28 
B. 
Confidentiality of Study Specimens ................................................................ 29 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 30 
22.0 Withdrawal of Subjects* ........................................................................................ 32 
23.0 Risks to Subjects* .................................................................................................. 32 
24.0 Potential Benefits to Subjects* .............................................................................. 34 
25.0 Compensation for Research-Related Injury ........................................................... 34 
26.0 Economic Burden to Subjects ................................................................................ 35 
27.0 Compensation for Participation ............................................................................. 35 
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* ........................................................ 44 
 
 
 

 
 
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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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PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
A cross sectional study of insulin resistance and cognitive function scores in patients with 
prostate cancer on androgen deprivation therapy (ADT). 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Paresh Dandona, MD, PhD 
1000 Young’s Road 
Williamsville, NY 14221 
pdandona@kaleidahealth.org 
 
Gurkamal Chatta, MD 
Roswell Park Comprehensive Cancer Center 
Elm and Carlton Street 
Buffalo, New York 14263 
716-845-3117 
Gurkamal.Chatta@roswellpark.org 
 
SECONDARY INVESTIGATORS: 
 
Husam Ghanim, PhD 
Itivrita Goyal, MD 
Manu Raj Pandey, MD 
Rajeev Sharma, MD 
Robert Pili, MD 
 

 
 
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VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: 10.05.2020 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources page in 
Click IRB. 
Response: Sponsored with Investigator Initiated Funds (IIF)  
 
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: NA 
 
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 

 
 
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Department: Diabetes and Endocrinology 
 
1.0 Study Summary 
       
Study Title 
A cross sectional study of insulin resistance and cognitive 
function scores in patients with prostate cancer with or 
without androgen deprivation therapy (ADT) 
 
Study Design 
Cross sectional study 
 
Primary Objective 
To investigate the possible cellular and molecular 
mechanisms underlying insulin resistance in patients 
undergoing androgen deprivation therapy for prostatic 
carcinoma including determining the expression of insulin 
signaling genes and proinflammatory genes associated with 
insulin resistance. 
 
Secondary 
Objective(s) 
1. Determine level of insulin resistance at different stages of 
ADT treatment compared to those not on ADT 
2. Correlate level of insulin resistance to the expression of 
insulin signaling genes and inflammatory mediators 
associated with insulin resistance 
3. Determine the effect of insulin resistance on body 
composition of men undergoing ADT 
 
4. Determine cognitive function scores in patients receiving 
ADT at various stages.  
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
None 
IND/IDE #  
NA 
Study Population 
Patients with Prostate cancer from Roswell Park 
Comprehensive Cancer Center 
Sample Size 
40 
Study Duration for 
individual 
participants 
Up to 7 days 

 
 
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Study Specific 
Abbreviations/ 
Definitions  
 
 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
PRIMARY OBJECTIVE 
To investigate the possible cellular and molecular mechanisms underlying or associated 
with insulin resistance in patients undergoing androgen deprivation therapy for prostatic 
carcinoma including determining the expression of insulin signaling genes and 
proinflammatory genes associated with insulin resistance. 
SECONDARY OBJECTIVES 
1. Determine level of insulin resistance at different stages of ADT treatment compared to 
those not on ADT 
2. Correlate level of insulin resistance to the expression of insulin signaling genes and 
inflammatory mediators associated with insulin resistance 
3. Determine the effect of insulin resistance on body composition of men undergoing 
ADT. 
4. Determine cognitive function scores in patients receiving ADT at various stages.  
 
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 ADT results in increase in insulin resistance and in inflammatory 
mediators which may interfere with insulin signal transduction. We hypothesize that 
ADT results in greater adiposity and an increase in plasma insulin and glucose 
concentrations with a concomitant increase in HOMA-IR, plasma TNFα and IL-1β with a 
decrease in the expression of IRβ, IRS-1, AKT and GLUT-4 in adipose tissue 
 
3.0 Scientific Endpoints* 
 
3.1    Describe the scientific endpoint(s), the main result or occurrence under study.   
 

 
 
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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 
• Determine levels of IRS-1 serine phosphorylation in adipose tissue and MNC as 
marker of inflammation induced insulin resistance 
• Changes in expression of insulin signaling genes; IR, IRS-1 and AKT-2 in both 
adipose tissue and mononuclear cells and expression of GLUT-4 in adipose tissue 
in subjects with prostate cancer on ADT compared to those not on ADT 
• Changes in expression of proinflammatory genes that interfere with insulin 
signaling transduction (TNF-α, IL-1, IKK-, SOCS-3, PTB-1B, JNK-1, TLR-4) 
in adipose tissue and mononuclear cells will be assessed 
 
SECONDARY ENDPOINTS 
• Comparison in expression of insulin signaling genes and of proinflammatory 
genes associated with insulin resistance in adipose tissue and mononuclear cells 
among subjects with prostate cancer at various stages of ADT 
• Measurement of insulin resistance by HOMA-IR method in subjects with prostate 
cancer on ADT compared to those not on ADT  
• Correlation of insulin resistance as measured by HOMA-IR to the expression of 
insulin signaling genes and proinflammatory genes associated with insulin 
resistance in adipose tissue and mononuclear cells 
• Changes in plasma levels of glucose, insulin and lipid concentrations in subjects 
with prostate cancer on ADT compared to those not on ADT 
• Changes in plasma concentrations of inflammatory markers like free fatty acids 
(FFA), CRP (C-reactive protein), leptin, adiponectin, TNF- and IL-1 will be 
assessed 
• Changes in lean body mass and fat mass; total and regional as measured by 
DEXA scan 
• Changes in cognitive function scores in subjects with prostate cancer on ADT 
compared to those not on ADT 
 
4.0 Background* 

 
 
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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:  
Prostate cancer (PrCa) is the most common non-cutaneous malignancy amongst men in the 
United States. Early stage, organ-confined PrCa can be cured by surgery or radiotherapy. 
While the majority of men are diagnosed with early stage disease, many present with more 
advanced disease or are otherwise not good candidates for curative therapies. In addition, 
one third of patients with localized disease will eventually develop metastatic PrCa. The 
mainstay treatment of locally advanced, as well as recurrent or metastatic PrCa is androgen 
deprivation therapy (ADT) [1], which blocks the production of male hormones and induces 
tumor cell apoptosis [2]. 
ADT either via castration or more frequently, gonadotropin-releasing hormone (GnRH) 
agonists (such as leuprolide), reduces serum testosterone (T) to castrate levels [3]. Despite 
initial responses, almost all patients will eventually develop disease progression, which in 
the presence of continuous ADT is defined as castration resistant PrCa (CRPC). Some 
CRPC patients may respond for a number of years to sequential administration of more 
potent anti-androgens combined with ongoing continuous ADT [4]. Thus, it is not unusual 
for men with advanced PrCa to be on continuous ADT for many years. 
ADT resulting in drastically low testosterone levels can have multitude of adverse effects 
on the metabolic, cardiovascular and bone health in men with prostate cancer. Prostate 
cancer patients receiving ADT experience bone loss, muscle loss and increased fat mass 
(sarcopenic obesity), and increased insulin resistance; thus leading to increased risk of 
development of Type 2 Diabetes Mellitus (T2DM). These changes can be seen as early as 
within 3 months of therapy and continue to occur even after 2 years on ADT therapy (5). 
One of the earliest metabolic changes seen with ADT is hyperinsulinemia which is 
associated with fat mass increase. Sarcopenic obesity is a new term used for combination 
of excess weight and reduced muscle mass (6). The earliest prospective study on body 
composition and insulin resistance following ADT in men with non-metastatic prostate 
cancer was conducted by Smith et al in 2001 (7). The study showed ADT in newly 
diagnosed men with PCa resulted in increase in fat mass from 20.2±9.4 kg at baseline to 
21.9±9.6 kg at 3 months (P=0.008), while lean body mass decreased from 63.2±6.8 kg at 
baseline to 61.5±6.0 kg (P=0.016). Another prospective study confirmed these changes by 
showing that there was a 9.4% increase (p value < 0.001) in subcutaneous fat and 2.7% 
decrease (p value < 0.001) in lean mass after 12 months of ADT in 40 men (8). Visceral fat 
did not change in this study. Similar findings were also observed in a recent study of 34 
men receiving ADT and 29 men with prostate cancer but not receiving ADT (9). 
Subcutaneous fat mass increased by 3.4 kg and lean mass decreased by 1.5 kg after 12 
months of ADT.  

 
 
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Several retrospective and prospective studies have shown increased risk development of 
insulin resistance and T2DM in PCa patients receiving ADT. In the same study done by 
Smith et al(7), they also showed increase in serum fasting serum insulin levels from 11.8 
mU/L at baseline to 19.3 mU/L at 3 months. A short term study showed statistically 
significant increase in fasting serum glucose levels in PCa patients on ADT for 6 months 
suggesting compensatory hyperinsulinemia(10). A cross sectional study by Basaria et al, 
which recruited men on ADT for at least 12 months and age matched men with PCa not on 
ADT, showed hyperinsulinemia and fasting hyperglycemia more prevalent in ADT group 
than the control group(11,12) and the severity of these metabolic complications was directly 
related to the duration of ADT (12). Subsequent population based study looked into the 
health data of 73,196 men > 66 years old and showed that men undergoing ADT 
experienced a 44% increase in development of diabetes than men not undergoing ADT (13). 
Similar analysis of a Canadian Database with an age matched cohort study including about 
20,000 men > 66 years of age treated for prostate cancer found increased risk of diabetes 
(by 16%) in men treated with ADT compared to ADT naïve men (14). These men were 
followed for an average of 6.47 years. Thus, long term ADT has been shown to cause 
increased incidence of sarcopenic obesity, insulin resistance and T2DM, all leading to 
increased adverse metabolic and cardiovascular outcomes.  
Studies have shown an increase in insulin resistance as measured by HOMA of insulin 
resistance (HOMA-IR) in subjects with low Testosterone levels irrespective of diabetes 
(15,16). And this is mediated through an increase in inflammatory mediators that interfere 
with insulin signaling. Our previous study on hypogonadal men in T2DM have shown that 
patients with hypogonadotropic hypogonadism (HH)  have an increase in insulin resistance 
and increase in inflammatory mediators, which may interfere with insulin signal 
transduction(17). Our results clearly showed that type 2 diabetes patients with HH had 
significant increase in insulin resistance (as measured by hyperinsulinemic-euglycemic 
clamps, decreased GIR by 36%) compared to the type 2 diabetes patients without HH. 
There was a marked reduction in expression of IR-, IRS-1, AKT-2 and GLUT-4 in 
adipose tissue, the major genes mediating insulin signaling in the adipose tissue in HH men 
compared to eugonadal men. We also showed in the same study, that replacement of 
testosterone for 6 months lead to an increase in insulin sensitivity (measured through HE 
clamps), significant increase in the expression of above genes in adipose tissue and 
suppression of inflammatory mediators which interfere with insulin signaling.  This 
explains the mechanism of increased insulin resistance in hypogonadal men reversed by 
testosterone supplementation. 
Several reports have also linked the use of ADT to cognitive decline in men with prostate 
cancer[18]. Gonzales et al. reported in patients on ADT for prostate cancer had a statistically 
significant impairment in cognitive function compared to an education and age matched 
cohort of patient not on ADT as early as 6 months[19]. A recently published large 
retrospective analysis of more than 150,000 patients with prostate cancer who were 
followed for a period of at-least 10 years showed an increase in the diagnosis of 
Alzheimer’s disease (AD) and dementia in patients treated with ADT compared to patient 

 
 
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Page 10 of 45 
 
who did not receive ADT. The HR for AD and dementia was proportional to the doses of 
ADT with higher HR seen in patients who received >4 doses of ADT[20]. 
 
4.2 Include complete citations or references.  
Response:  
1. Gilbert SM, Kuo YF, Shahinian VB. Prevalent and incident use of androgen 
deprivation therapy among men with prostate cancer in the United States. Urol Oncol 
2011;29(6):647-53. 
2. Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. 
JAMA: the jour/jama.294.2.238. 
3. Grossmann M, Zajac JD. Management of side effects of androgen deprivation therapy. 
Endocrinology and metabolism clinics of Nor nal of the American Medical Association 
2005;294(2):238-44. 
4. Sartor O, de Bono JS. Metastatic Prostate Cancer. N Engl J Med 2018;378(17):1653-
54. 
5. Collins L, Basaria S. Adverse effects of androgen deprivation therapy in men with 
prostate cancer; a focus on metabolic and cardiovascular complications. Asian Journal 
of Andrology 2012; 14: 222-225. 
6. Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new 
category of obesity in the elderly. Nutr Metab Cardiovasc Dis 2008;18:388. 
7. Smith JC, Bennett S, Evans M, Kynaston HG, Parmar M et al. The effects of induced 
hypogonadism on arterial stiffness, body composition, and metabolic parameters in 
males with prostate cancer. J Clin Endocrinol Metab 2001; 86: 4261–7. 
8. Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, and 
Kantoff PW. Changes in body composition during androgen deprivation therapy for 
prostate cancer. The Journal of clinical endocrinology and metabolism. 2002;87(2):599-
603 
9. Cheung AS, Hoermann R, Dupuis P, Joon DL, Zajac JD, and Grossmann M. 
Relationships between insulin resistance and frailty with body composition and 
testosterone in men undergoing androgen deprivation therapy for prostate cancer. 
European journal of endocrinology. 2016;175(3):229-37. 
10. Nishiyama T, Ishizaki F, Tsutomu A, Shimura H, Takahashi K. The influence of 
androgen deprivation therapy on metabolism in patients with prostate cancer. J Clin 
Endocrinol Metab 2005; 90: 657–60. 

 
 
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Page 11 of 45 
 
11. Basaria S, Muller DC, Carducci MA, Egan J, Dobs AS. Hyperglycemia and insulin 
resistance in men with prostate carcinoma who receive androgen deprivation therapy. 
Cancer 2006; 106: 581–8. 
12. Basaria S, Muller DC, Carducci MA, Egan J, Dobs AS. Relation between duration of 
androgen deprivation therapy and degree of insulin resistance in men with prostate 
cancer. Arch Intern Med 2007; 167: 612–3. 
13. Keating NL, O’Malley AJ, Smith MR. Diabetes and cardiovascular disease during 
androgen deprivation therapy for prostate cancer. J Clin Oncol 2006; 24: 4448–56. 
14. Alibhai SM, Duong-Hua M, Sutradhar R, Fleshner NE, Warde P et al. Impact of 
androgen deprivation therapy on cardiovascular disease and diabetes. J Clin Oncol 
2009; 27: 3452–8. 
15. Hamilton EJ, Gianatti E, Strauss BJ, et al. Increase in visceral and subcutaneous 
abdominal fat in men with prostate cancer treated with androgen deprivation therapy. 
Clin Endocrinol (Oxf) 2011;74:377–383 
16. Tsai EC, Matsumoto AM, Fujimoto WY, Boyko EJ. Association of bioavailable, free, 
and total testosterone with insulin resistance: influence of sex hormone-binding globulin 
and body fat. Diabetes Care 2004;27:861–868 
17. Dhindsa S, Ghanim H, Batra M, Kuhadiya ND, Abuaysheh S, Sandhu S, Green K, 
Makdissi A, Hejna J, Chaudhuri A, Punyanitya M, Dandona P. Insulin resistance and 
inflammation in hypogonadotropic hypogonadism and their reduction after testosterone 
replacement in men with type 2 diabetes. Diabetes Care. 2016 Jan 1;39(1):82 
18. Treanor, C.J., J. Li, and M. Donnelly, Cognitive impairment among prostate cancer 
patients: An overview of reviews. Eur J Cancer Care (Engl), 2017. 26(6) 
19. Gonzalez, B.D., H.S. Jim, M. Booth-Jones, B.J. Small, S.K. Sutton, H.Y. Lin, J.Y. 
Park, P.E. Spiess, M.N. Fishman, and P.B. Jacobsen, Course and Predictors of Cognitive 
Function in Patients With Prostate Cancer Receiving Androgen-Deprivation Therapy: A 
Controlled Comparison. J Clin Oncol, 2015. 33(18): p. 2021-7. 
20. Jayadevappa, R., S. Chhatre, S.B. Malkowicz, R.B. Parikh, T. Guzzo, and A.J. Wein, 
Association Between Androgen Deprivation Therapy Use and Diagnosis of Dementia in 
Men With Prostate Cancer. JAMA Netw Open, 2019. 2(7): p. e196562. 
 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
It will be a cross sectional study with 2 groups of patients.  

 
 
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One group will be men with prostate cancer in various stages of ADT and the control 
group will be men with prostate cancer not on ADT. 
 
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:  
NA 
 
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:  
NA 
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: 
 
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:  

 
 
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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:  
40 
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 130 to 150 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 patients per month begin treatment with ADT 
in the GU oncology clinic. We anticipate that a majority (10) will be eligible and 30% (3) 
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. Male, age ≥ 18 years of age. 
2. Body Mass Index of > 25 kg/m2 
3. Biopsy-confirmed prostate adenocarcinoma of any stage/grade currently on androgen 
deprivation therapy (ADT) for minimum of 3 months 
4. Biopsy-confirmed prostate adenocarcinoma of any stage/grade not on ADT for control 
group 
5. Hemoglobin > 11 g/dL, Creatinine < 1.5x ULN and liver function tests < 2x ULN 
6. Participant must be able to read, write, and understand the English language and be 
able to provide written consent 

 
 
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7. Participant must understand the investigational nature of this study and sign an 
Independent Ethics Committee/Institutional Review Board approved written informed 
consent form prior to receiving any study related procedure 
 
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. Known clinically significant severe COPD, ischemic heart disease, congestive 
heart failure, and/or significant cardiac arrhythmias 
2. Any patient with known diabetes (A1c > 6.4%) or an anti-diabetic drug 
3. Any condition contraindicating additional blood collection beyond standard of care 
4. Subjects with known allergy to lidocaine (this is used to anesthetize area for fat 
biopsy) 
5. Unwilling or unable to follow protocol requirements 
6. Any condition which in the Investigator’s opinion deems the participant an 
unsuitable candidate to undergo  study procedures. 
7. Subjects on chronic use of androgens, or opiates in the last 6 months or with 
panhypopituitarism, 
congenital 
HH 
(hypogonadotropic 
hypogonadism), 
prolactinoma, head trauma 
 
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 
☐ 
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.  

 
 
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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 are able to read, write and understand it.  This 
population is less than 10% of the total population 
We are excluding non-English speaking individuals as this is a small study and no 
benefits will be withheld.  
 
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. 
 
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:  

 
 
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Page 16 of 45 
 
☒ 
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.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: 

 
 
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Prospective participants referred to the research center from Roswell Park 
Comprehensive Cancer Center (RPCCC) and Great Lakes Cancer Care GU clinics will be 
asked about their interest in participating in the research study. If the subject wants to 
participate in the study, they will be referred to the research coordinator at the Diabetes 
and Endocrinology Center of WNY to screen for the study, and sign the informed consent 
form. 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 
will be taken in order to evaluate CBC, HbA1c, and CMP. 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: 
Study participants will be recruited from the RPCCC (Roswell Park Comprehensive 
Cancer Center) GU Oncology clinical program (Hematology and Oncology, Urology, and 
Radiation Oncology), Prostate Cancer Survivorship group and Biodata Repository (BDR) 
and Great Lakes Cancer Care GU clinics by the attending physicians. Patient records will 
be reviewed at the time of clinical encounter as well as from the BDR 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. If a 
participant is identified from the BDR, they will be contacted through phone by the GU 
team (members listed in the study) about their interests in participating in research. The 
GU team will refer the interested participants to the Diabetes and Endocrinology 
Research Center of Western New York where they will be screened and consented 
 
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:  

 
 
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Patient charts will be screened at the time of clinical encounter as well as from the BDR 
according to the study inclusion and exclusion criteria by the clinical staff and physicians 
of GU oncology group at RPCCC and Great Lakes Cancer Care GU clinics. If the patient 
qualifies and is of consenting age, the physicians will speak to them about their interests 
in participating in research. If a participant is identified from the BDR, they will be 
contacted through phone by the GU team (members listed in the study).  If the patient 
agrees, attending physician will give their information to the research coordinator at 
Diabetes and Endocrinology Center of WNY to be contacted for further evaluation. 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 taping to ensure 
there will be no IRB-required revisions, provided the IRB also reviews and approves the 
final version. 
 Response:  
Patients will be identified through screening of clinical charts from RPCCC GU oncology 
clinic program, Prostate Cancer Survivorship group, Biodata Repository (BDR) and 
Great Lakes Cancer Care GU clinics. 
 
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:  
This is a cross sectional study designed to establish the cellular and molecular 
mechanisms underlying insulin resistance and the interference in insulin signal 
transduction in patients undergoing Androgen Deprivation Therapy for prostatic 
carcinoma.  
Patients interested in participating who meet the inclusion/exclusion criteria and who 
agree to undergo blood draws, fat biopsy and DEXA imaging will be identified by the 

 
 
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Page 19 of 45 
 
GU team at RPCCC and Great Lakes Cancer Care GU clinics. These patients will be 
referred to the Diabetes and Endocrinology Research Center of WNY where they will 
undergo blood draws in fasting state.  
Screening Visit: 
Participants will be asked to complete the following procedures prior to participating in 
the study (screening visit): 1) Informed consent; 2) Medical History 3) Physical Exam; 4) 
Blood draws for fasting labs before 10:00 am including; CBC, CMP, and HbA1c. 30 ml 
of blood will be drawn at this visit. Participants will be given a urine container for 24-hr 
urine collection to be brought on the study visit day.  
Visit Day: 
If they meet the criterion for the study, they will be called in for the study visit where 
they will undergo blood draws in fasting state. HOMA-IR method will be used to 
determine insulin resistance. 40 ml of blood will be drawn at this visit.  
Subcutaneous fat biopsies will be performed. Participants will be referred to get a DEXA 
scan within 7 days of getting fat biopsies.   
 
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 cold sterile 
PBS and centrifuged to remove the PBS. Total RNA, nuclear extracts and total cell 
lysates will be prepared from the adipose tissue.  
 
Imaging: 
Lean body mass and fat mass, total and regional (appendicular and trunk) will be 
measured by DEXA scan within 7 days of fat biopsy. 
 
Cognitive score questionnaire: 
The subjects will be asked to complete questionnaire to assess their cognitive function on 
the day of the study visit after they undergo fat biopsy and blood draw. 
MMSE (Mini-mental State Examination) test and MoCA (Montreal Cognitive 
Assessment) questionnaires will be given to be completed.  
 
12.2 Describe what data will be collected.   

 
 
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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:  
Clinical Laboratory Assay: 
All measurements will be carried out by Quest Diagnostics. Total testosterone and 
estradiol concentrations will be measured by liquid chromatography-tandem mass 
spectrometry. Tracer equilibrium dialysis is considered the gold standard for measuring 
free steroid hormone concentrations and this methodology will be used to measure the 
free testosterone and free estradiol. SHBG, LH and FSH concentrations will be measured 
by a solid phase, chemiluminescent immunometric assay. Free testosterone 
concentrations will also be measured from the concentrations of total testosterone, SHBG 
and albumin by the formulas of Sodergard et al.  
 
Mononuclear cell Isolation: 
Blood samples will be collected in Na-EDTA and carefully layered on lymphocyte 
medium. Samples will be centrifuged, and two bands separate out at the top of the red 
blood cell pellet. The mononuclear cell (MNC) band will be harvested and washed twice 
with Hanks’ balanced salt solution. This method yields > 95% MNC preparation.  
 
Quantifications of mRNA Expression by RT-PCR: 
Expression of inflammatory mediators involved in insulin resistance and those that 
mediate insulin signaling will be tested by RT-PCR in mRNA isolated from MNC and 
adipose tissue. Total RNA will be isolated from MNC and adipose tissue using a 
commercially available RNAqueous-4PCR kit and adipose tissue RNA Isolation kit 
(Ambion, Austin, TX). Real-time RT-PCR will be performed using the Stratagene 
Mx3000P qPCR system (La Jolla, CA), SYBR Green Master Mix (Qiagen, CA), and 
gene-specific primers for IKK-b, SOCS-3, PTEN, PTP-1B, JNK-1, TLR-4, IL-1b, IR, 
IRS-1, AKT-2, and GLUT4 (Life Technologies, Frederick, MD). All values will be 
normalized to the expression of a group of housekeeping genes including actin, ubiquitin 
C, and cyclophilin A. The normalization factor used is calculated by Gene Norm software 
and is based on the values of all housekeeping genes used. 
 
Western Blotting: 
MNCs and adipose tissue total cell lysates will be prepared, and electrophoresis and 
immunoblotting will be carried out as described before. Polyclonal antibodies against IR 
(Abcam, Cambridge, MA), AKT-2, SOCS-3, IKK-b, and actin (Santa Cruz 
Biotechnology, Santa Cruz, CA) will be used, and all values will be corrected for loading 
to actin. 

 
 
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Page 21 of 45 
 
 
Plasma measurements: 
Free fatty acid (FFA) levels will be measured by a colorimetric assay (Wako Chemicals, 
Richmond, VA). ELISA will be used to measure plasma concentrations of glucose 
(Cayman Chemical), insulin (EMD Millipore, Billerica, MA), CRP (American 
Diagnostica, Inc.), leptin, adiponectin, tumor necrosis factor (TNF)-a, and interleukin 
(IL)-1b (R&D Systems, Minneapolis, MN

 
Page 22 of 45 
 
 
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:  
Please see forms for screening visit and for regular visits 
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 
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:  
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:  
6 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:  

 
 
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IRB Version: 5/6/19 
Up to 7 days 
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:  
12 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:  
The study will be conducted at the following centers: 
Roswell Park Comprehensive Cancer Center – GU oncology clinic and Great 
Lakes Cancer Care GU clinics; where recruitment of patients will occur 
Diabetes and Endocrinology Center of WNY – Where procedures as outlined 
above will occur.  
 
The Diabetes Research Center has facilities and exam rooms available for 
infusion studies and presence of study coordinator and registered nurse for data 
collection and blood work at all times. Equipment include ultra-low freezers for 
sample storage, centrifuges, microscopes for sample preparation, infusion pumps, 
ELISA, PCR and immunoblotting instrumentation. CTRC location is a fully 
equipped laboratory 
 
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, 

 
 
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IRB Version: 5/6/19 
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. 
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:  

 
 
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IRB Version: 5/6/19 
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 GU team at Roswell Park Comprehensive Cancer Center and Great Lakes 
Cancer Care GU clinics who will be reviewing the patients’ records for 
recruitment include the attending physicians (Dr. Chatta and Dr. Pili) and the 
fellows (Dr. Pandey and Dr. Goyal) all of whom are listed on the study.  
 
Describe other resources available to conduct the research.  
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 weekly research 
meetings are conducted to discuss the recruitment rate, resolve and discuss issues 
related to the conduct, safety, analysis of the study and related publications. PI is 
expected to spend 5% 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 patient 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 physician (Investigators and Co-Investigators) 
who will be available to address any adverse effects or other questions during the 
course of the study  
 

 
 
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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:  
Education through meetings, conferences and discussions 
 
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:  
As the subjects will be recruited from RPCCC GU oncology clinics and Great 
Lakes Cancer Care GU clinics. There is a global reliance agreement between 
Roswell Park CCC and UB IRBs, thus RPCCC will rely on the UB IRB review of 
this study. 
☐ 
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:  
Patient charts will be screened at the time of clinical encounter as well as from the 
BDR according to the study inclusion and exclusion criteria by the clinical staff 
and physicians of GU oncology group at RPCCC and Great Lakes Cancer Care 
GU clinics. If the patient qualifies and is of consenting age, the physicians will 
speak to them about their interests in participating in research. If the patient 
agrees, they will be asked to make an appointment at the Diabetes and 
Endocrinology Center of WNY to review and sign the consent. They will do this 
in a private, screen off area of the research department and will be allowed to 
discuss the consent in detail with the research coordinator and or study doctor. 

 
 
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IRB Version: 5/6/19 
Patient will be no 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 
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 
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:  
The demographic features of the population and screening lab results will be 
displayed in tables. 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. 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:  
Based on our previous study, HH men have greater insulin resistance by 30% 
compared to eugonadal men. Therefore, a sample size of 20 patients in each group 
is sufficient to provide adequate power (80%) to detect a significant difference 
(p<0.05) in insulin resistance of ≥30% between patients with ADT (negligible 
testosterone) and non-ATD patients (low to normal testosterone) assuming the 
standard deviation of the diffidence is ≤30%. and a drop-out rate of about 15%. 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 

 
 
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IRB Version: 5/6/19 
Response:  
Three investigators and research nurse will double check the accuracy of collected 
data. All laboratory testing will be standardized using references and standards. 
 
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. All subject data will be stored on a 
deidentified coded collection form. Collected data will also be stored on a 
password protected computer in the research department and all subject files will 
only be accessible by authorized study personnel. This includes Red cap (research 
electronic data captures) software. 
 
20.2 
A.  How long will the data be stored? 
Response:  
Data storage have no expiration date and will be stored for a minimum of 7 years. 
The researchers may continue to rely on this for future use in research study. 
 
20.3 
A.  Who will have access to the data? 
Response:  
Those physicians, nurses, and laboratory staff that are on all documentation for 
the study will have access to the data. 
 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  

 
 
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IRB Version: 5/6/19 
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: 
All data are stored at one location 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  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:  
Specimens storage has no expiration date and will be stored for a minimum of 7 
years. The researchers may continue to rely on this for future use in research 
study 
 
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 
 

 
 
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IRB Version: 5/6/19 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
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:  
We do not expect subjects to experience adverse reaction from fat biopsy 
procedures. However, patients will be under close monitoring by our staff during 
the entire process of the biopsy procedure. The investigators will assess other 
risks including the physical, psychological, social, legal and economic harm to 
these patients. The investigators listed above 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:  

 
 
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Blood Pressure, Height, Weight, and adverse reaction reported by subjects are 
monitored at the visit 
 
21.3 Describe any safety endpoints. 
Response:  
NA 
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:  
On site 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 after all study visits 
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. 
Response:  
Safety data will be reviewed every three months during the duration of the study. 
Study endpoint data will be reviewed once after half of the recruited patients have 
completed the study and then at the end of the study 
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A (since you are not listing any safety endpoints) 
 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 

 
 
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Response:  
Serious adverse reaction/ side effects from blood draws or fat biopsy procedure 
• Significant high incidence of SAE and events leading to withdrawal of 
subjects determined based on the continuous review by the investigators. 
•  
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 reactions during fat biopsy procedure (done on the day of study 
visit only) or DEXA scan or from blood draws (done at both screening visit and 
study visit). 
 
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 principal investigator of the study can remove a participant from the research 
study without their approval if for any reason he/she feels is appropriate, 
including: severe side effect, injury or medical condition which may place 
subjects at risk of further complications if they continue to participate, failure to 
keep the scheduled appointments, or other administrative reasons 
 
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* 

 
 
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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 administration of 
intravenous (IV) line, which includes mild bruising at the site of IV line, which 
should resolve in few days. They will also be informed about the possibility of 
infiltration of the IV line at the time of performing blood draws in which case 
another IV line at different site will be secured and this may lead to bruising at 
more than one sites. Serious risks associated with IV puncture 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.  
The risks associated with the DEXA scan are generally considered to be minimal. 
However, subjects may experience some discomfort when placed in the proper 
positioning for optimal scanning. DEXA scans involve exposure to radiation. This 
radiation dose is not standard of care and will occur only as a result of 
participation in the study. At doses much higher than received from a DEXA 
scan, radiation is known to increase the risk of developing cancer after many 
years. At the dose subjects will receive, it is very likely that there will be no 
effects at all. 
 
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:  

 
 
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We will collect no more than 40 ml of blood on each visit (screening visit and 
study visit). We will follow standard sterilization procedures. Snacks will be 
provided at end of study. Safety data will be collected at screening and during the 
study. 
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: N/A 
 
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 limited to male patients only 
 
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:  
There will be no direct benefit to the participants from this research study or from 
the biomarker assessment, and results will not be reported in the 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.   

 
 
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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 will be covered. Participants will not be subjected to any 
out of pocket cost 
☐ 
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 ($50), and DEXA ($25) 
 
*Total compensation for all completed visits: $100.00  

 
 
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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. 
☐ 
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.   
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.   

 
 
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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. 
 
NOTE: The response to this Section should correspond with your response to 
Section 8.4 of this protocol. 
Response:  
NA 

 
 
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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:  
 
 
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. 
Response:  
 

 
 
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☐ 
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) 

 
 
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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 
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).”  

 
 
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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 
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 

 
 
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☐ 
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 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). 

 
 
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• 
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)”): 
• 
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. 

 
 
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IRB Version: 5/6/19 
• 
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 
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 or -80 freezer at 
the research facility of the Diabetes and Endocrinology Center of WNY 
and at 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 
 
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 result.. 

 
 
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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.