A Causative Role for Amylin in Diabetic Peripheral Neuropathy
Conditions: Type2 Diabetes, Peripheral Neuropathy
Sponsor: Zabeen Mahuwala, MD

PROTOCOL TYPE
Which IRB
Medical
NonMedical
Protocol Process Type
Exemption
Expedited
Full
(Must be risk level 1)
Section 1 Page 1 of 1
IRB Approval
1/25/2018
IRB # 42732

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Section 3 Page 2 of 2
42732

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SUBJECT DEMOGRAPHICS
Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 18 to 99
Indicate the targeted/planned enrollment of the following members of
minority groups and their subpopulations
(Please note: The IRB will expect this information to be reported
at Continuation Review time):
Enter Numbers Only!
Ethnic Origin
#Male
#Female
American
Indian/Alaskan
Native:
Asian:
Black African
American:
Hispanic/Latino:
Native
Hawaiian/Pacific
Islander:
White/Caucasian:
Other or
Unknown:
If unknown, please
explain why: Unable to estimate at this time
Indicate the categories of subjects and controls to be included in the
study. Depending on the subject category applicable to your research
you may be required to complete additional forms. [Note, if the study
does not involve direct intervention or direct interaction with subjects,
(e.g., record-review research, outcomes registries), do not check mark
populations which the research does not specifically target. For
instance, a large record review of a diverse population may incidentally
include a prisoner or an international citizen, but, if the focus or intent of
the study has nothing to do with that status, you do not need to check
those category(ies).]
Check All That Apply (at least one item must be selected)
Children (individuals under
age 18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine
Students
UK Medical Center
Residents or House Officers
Impaired Consent Capacity
Adults
ADDITIONAL INFORMATION:
Children
Emancipated Minors
Impaired Consent Capacity Adults:
Instructions; 
Link to required Form
Students as Subjects - Guidances:
- University of Kentucky Students
[PDF]
- College of Medicine Students
[requirement of OME] 
- K-12 [PDF]
Section 5 Page 1 of 3
42732

Pregnant
Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking
International Citizens
Normal Volunteers
Military Personnel and/or
DoD Civilian Employees
Patients
Appalachian Population
UKMC Residents or House Officers
[see requirement of GME]
Non-English Speaking [see
instructions for recruitment and E-IRB
Research Description section on
same topic]
Prisoners
International Citizens [HTML] (DoD
SOP may apply [PDF])
Military Personnel and/or DoD Civilian
Employees (DoD SOP may apply
[PDF])
Section 5 Page 2 of 3
42732

Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
The next questions involve assessment of the study relative to potential recruitment of subjects with impaired consent capacity (or
likelihood).
Check this box if your study does not involve direct intervention or direct interaction with
subjects (e.g., record-review research, secondary data analysis). (you will not need to answer
the impaired consent capacity questions)
Does this study focus on adult subjects with any of the clinical conditions listed below
that present a high likelihood of impaired consent capacity or fluctuations in consent
capacity? (see examples below)
Yes
No
If Yes, go to the following link and complete and attach the indicated form unless you are filing for an exemption
certification: http://www.research.uky.edu/ori/ORIForms/FormT/Scale.asp
Examples of such conditions include:
Attachments
Section 5 Page 3 of 3
42732

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I am requesting alteration of the informed consent process.
If you checked the box for this item, describe which elements of consent will be altered, and/or omitted, and justify the
alteration.
SECTION 2.
The IRB may consider your request provided that all of the following conditions apply to your research and are
appropriately justified. Explain in the space provided for each condition how it applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent
information after they have participated in the study.
Section 6 Page 2 of 3
42732

Request for Waiver of Documentation of Informed Consent Process
If you are requesting IRB approval for waiver of the requirement for documentation of informed consent (i.e. telephone
survey or mailed survey, internet research, or certain international research), your research activities must fit into one of two
regulatory options: 
1) The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (i.e., a study that involves participants who use illegal drugs). 
2) The research presents no more than minimal risk to the participant and involves no procedures for which written consent is
normally required outside of the research context (i.e. a cover letter on a survey, or a phone script). 
Select the option below that best fits your study, and explain in the space provided how your study meets the criteria for the
selected regulatory option. 
Note: The IRB cannot waive the requirement for documentation or alter the consent form for FDA-regulated research unless it
meets Option #2 below. FDA does not accept Option #1. 
Note: Even if a waiver of the requirement for documentation is approved by the IRB, participants must still be provided oral or
written (e.g., cover letter) information including all required and appropriate elements of consent so they have the knowledge
and opportunity to consider whether or not to participate. To help ensure required elements are included in your consent
document, please use the Cover Letter Template as a guide: English- [WORD] [RTF], Spanish- [WORD] [RTF] The cover
letter template was developed specifically for survey/questionnaire research; however, it may be useful as a guide for
developing a consent document for other types of research as well. 
Option 1
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves
subjects who use illegal drugs).
Under this option, each participant must be asked whether (s)he wants to sign a consent form; if the participant
agrees to sign a consent form, only an IRB approved version should be used.
Option 2
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Section 6 Page 3 of 3
42732

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RESEARCH DESCRIPTION
**!!!PLEASE READ!!!** Known Issue: The below text boxes do not allow symbols, web addresses, or special characters
(characters on a standard keyboard should be ok). If something is entered that the text boxes don't allow, user will lose
unsaved information.
Workaround(s):
Save your work often to avoid losing data.
Use one of the attachment buttons in this section, or under the Additional Information section to include the
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background: Provide an introduction and background information. Describe past experimental and/or clinical findings leading to the
formulation of your study. For research involving investigational drugs, describe the previously conducted animal and human studies.
You may reference grant application/sponsor’s relevant protocol pages and attach as an appendix in the E-IRB "Additional Information"
section. For research that involves FDA approved drugs or devices, describe the FDA approved uses of this drug/device in relation to
your protocol. Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference in the
applicable E-IRB "Study Drug" or "Study Device" section.
Impaired blood flow through microvessels (arterioles and capillaries) leads to irreversible damage to cells within the affected
watershed. In addition to hypertension and age, Type-2 diabetes (DMII) independently contributes to microvascular disease (1,2).
Distinct from other diabetic complications, the impact of diabetes on neurovascular function has not clearly been shown to correlate
with measures of hyperglycemia or peripheral glucose regulation (3,4). The pathophysiology underlying the association between
type-2 diabetes, vascular injury and neural damage, including CNS parenchymal loss and PNS neuropathy, remains uncertain.
Normally amylin, a byproduct of the synthesis of insulin by pancreatic ß-cells, crosses the blood brain barrier (5) and binds to neurons
in feeding centers (6-8) where it is believed to induce anorexic effects (9). Amylin aggregates are found in microvessels of pancreas,
brain, hearts and kidneys of individuals with DMII or obesity (10-13). We have demonstrated amylin aggregates in microvessels of
peripheral nerves in rats overexpressing human amylin (unpublished). It is unknown whether amylin deposits are a consequence or a
trigger of vascular injury, but they are clearly associated and may present a potential target for reducing diabetes-associated
microvascular disease. Furthermore, their accumulation in peripheral nerve microvasculature and red blood cells (RBCs) offers
possible foci for a peripheral biomarker of diabetes-induced CNS microvascular disease.
Objectives: List your research objectives. You may reference grant application/sponsor’s relevant protocol pages and attach as an
appendix in the E-IRB "Additional Information" section.
Hypothesis: Patients with DMII have significant amylin deposition in the peripheral vasa nervorum and on RBCs that correlates with
severity of clinical peripheral polyneuropathy and reduction of peripheral nerve conduction velocities (NCVs); these amylin measures
thereby become surrogates of microvascular disease and may serve as metrics of disease severity. Aim: Obtain serum HbA1c, skin
punch biopsy, RBCs, NCVs and clinical sensory examination from forty consenting adults previously diagnosed with DMII. Skin
biopsy from volar forearm and red blood cell samples will be processed for amylin deposition. This pilot study will provide preliminary
data to fuel a larger, potentially multi-center, clinical trial investigating the utility of peripheral amylin or RBC amylin as a quantitative
biomarker of microvascular disease that would include monitoring the effect of potential therapies. Measuring serum HbA1c will allow
for possible correlation to chronic extracellular glucose concentration. Based on our preliminary data from a rat model of type-2
diabetes that expresses human amylin in the pancreas, we anticipate an increased amylin deposition in the skin blood vessels with
the progression of type-2 diabetes as measured by sensory examination and NCVs.The ability to easily identify and target a potential
driver of microvascular disease may help prevent the devastating effects of the vascular complications of DMII, including
cardiovascular disease, retinopathy, nephropathy and dementia.
Study Design: Describe the study design (e.g., single/double blind, parallel, crossover, etc.). Indicate whether or not the subjects will
receive placebo medication at some point in the research procedures. Also, indicate whether or not the subjects will be randomized in
this study. You may reference sponsor’s protocol pages and attach as an appendix in the E-IRB "Additional Information" section.
(Including the study design table from a sponsor’s protocol is helpful to IRB members.)
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from the
study.
Research Repositories: If the purpose of this submission is to establish a research repository describe the repository design and
operating procedures. For relevant information to include, see question 22 of the UK IRB “Frequently Asked Questions (FAQs) on the
Return of Research Results or Incidental Research Findings” [PDF].
Forty patients with previously diagnosed DMII and referred to the Kentucky Neuroscience Institute Neuromuscular Laboratory for
nerve conduction velocity studies (NCVs) will be asked to participate in the study. Because this is a pilot study, every effort will be
made to select a broad distribution of patients who are mildly to severely symptomatic based on NCVs. • Informed consent will be
obtained from patients who have obtained NCVs as standard-of-care and are interested in participating. After those individuals sign
an IRB-approved informed consent, data will be collected including duration of DMII diagnosis, current medications, height and
Section 8 Page 1 of 9
42732

weight (to calculate body mass index [BMI]), family history of neuropathy, and results of blood tests if obtained within the previous 6
months to include comprehensive metabolic profile, complete blood count, lipid profile, vitamin B12, and thyroid stimulating hormone
to help exclude other common causes of peripheral neuropathy. Participants will then undergo a skin biopsy taken from the volar
forearm using a standardized kit and vibratory sensation will be measured over the tip of the 2nd digit (index finger) quantified using a
Rydel-Seiffer 128 Hz tuning fork), and venipuncture for blood samples utilizing the UK Healthcare Clinical Laboratories. Blood
samples will be collected for measure of RBC amylin (performed in Dr. Despa’s laboratory) and HbA1c (UK Healthcare Clinical
Laboratories), as well as those measures not performed in the previous 6 months to include metabolic profile, complete blood count,
vitamin B12, and thyroid stimulating hormone. Skin biopsies will be collected and stored in formalin. The formalin-fixed skin biopsy will
be paraffin embedded and sectioned for staining with an anti-amylin antibody as previously described (15). RBCs will be harvested
from collected samples. Cells will by lysed, protein concentration will be determined, and amylin will be detected by
immunofluorescence using enzyme-linked immunosorbent assay (ELISA) (14,15). The positive control for the amylin antibody is the
pancreatic tissue from a patient with type-2 diabetes. Negative controls for the amylin antibody are pancreatic and liver tissues from
amylin knockout (AKO) rats. Immunohistochemical staining and co-staining of the skin tissue with anti-amylin and anti-collagen IV
antibodies will be performed to assess the level of amylin deposition in the skin sample and the localization of amylin deposition with
respect to the blood vessel wall. To assess the density of the blood vessels that have amylin deposition, the tissue will be co-stained
with anti-amylin and anti-collagen IV antibodies; co-localization will be analyzed using immunoconfocal microscopy (14). One week
after NCV, biopsy, and venipuncture, participants will be scheduled for Pain Tests (see below) conducted at the Straus Behavioral
Science Building, UKMC. Statistical analysis: The two measures of amylin will be compared using the Bland Altman procedure to
determine how well the less invasive measure obtained from RBCs agrees with the more invasive punch biopsy measure. Then each
amylin measure will be correlated with the Hba1c and NCV/sensory examination measures to determine how well these levels
correlate with a measure of glucose control and with severity of neurologic disease. Correlations will be based on Pearson’s
correlation coefficient. With a sample size of 40 patients this will have 80% power to detect a correlation at least as large as 0.414 at
the 0.05 level of significance. The statistical design has been discussed with Dr. Richard J. Kryscio, consulting statistician for UK
COM.
Attachments
Back to Top
Study Population: Describe the characteristics of the subject population, such as anticipated number, age range, gender, ethnic
background and health status. Identify the criteria for inclusion and exclusion. Explain the rationale for the use of special classes such
as fetuses, pregnant women, children, institutionalized, adults with impaired consent capacity, prisoners or others who are likely to be
vulnerable. If women or minorities are included, please address how the inclusion of women and members of minority groups and their
subpopulations will help you meet your scientific objectives. Exclusion of these groups requires clear and compelling rationale that
shows inclusion is inappropriate with respect to the health of the subjects or that inclusion is inappropriate for the purpose of the study.
Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of
childbearing potential should not be excluded routinely from participation in clinical research. 
Provide the following information: 
• A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study
design;
• A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
• The proposed dates of enrollment (beginning and end);
• The proposed sample composition of subjects.
You may reference grant application/sponsor’s relevant protocol pages and attach as an appendix using the below attachment button.
Forty patients, age 18 years or older, with previously diagnosed DMII and referred to the Kentucky Neuroscience Institute
Neuromuscular Laboratory for nerve conduction velocity studies (NCVs) will be asked to participate in the study. Because this is a
pilot study, every effort will be made to select a broad distribution of male and female patients, regardless of ethnicity, who are mildly
to severely symptomatic based on NCVs.
Attachments
Subject Recruitment Methods & Privacy: Describe plans for the identification and recruitment of subjects, including how the
population will be identified, and how initial contact will be made with potential subjects by those having legitimate access to the
subjects' identity and the subjects' information. Describe the setting in which an individual will be interacting with an investigator. If
applicable, describe proposed outreach programs for recruiting women and minorities as participants in clinical research.
Please note: Based upon both legal and ethical concerns, the UK Medical Institutional Review Board (IRB) will not approve finder’s
fees for research studies. 
Subjects will be identified from the patient population that has been previously diagnosed with DMII and who were referred to the
Kentucky Neuroscience Institute Neuromuscular Laboratory for nerve conduction velocity studies (NCVs). The assessment for
eligibility will be done by Stephen Ryan, MD who will ask potential participants if they would like to be part of a research study of
patients with DMII who have been referred for NCVs. Patients deemed eligible for the study and interested in participating will be
approached to undergo participation in this study by a member of the research staff qualified to consent patients for the study. Forty
patients with previously diagnosed DMII and referred to the Kentucky Neurological Institute (KNI) Neuromuscular Laboratory for nerve
Section 8 Page 2 of 9
42732

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Informed Consent Process: Describe the consent/assent procedures to be followed, the circumstances under which consent will be
sought and obtained, the timing of obtaining informed consent, whether there is any waiting period between informing the prospective
subject and obtaining consent, who will seek consent (Note: all individuals authorized to obtain informed consent should be designated
as such in the E-IRB "Study Personnel" section of this application), steps taken to minimize the possibility of coercion or undue
influence, the method used for documenting consent, and if applicable who is authorized to provide permission or consent on behalf
of the subject. Describe, if applicable, use of specific instruments or techniques to assess and confirm potential subjects’
understanding of the nature of the elements of informed consent (i.e., research involving adult subjects with impaired consent capacity)
and/or a description of other written materials that will be provided to participants or legally authorized representatives. If you have a
script, please prepare it using the informed consent template as a guide, and submit it on a separate page. For additional information,
see the "Informed Consent Standard Operating Procedures (SOPs)" [PDF].
Informed Consent for Research Involving Emancipated Individuals
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel when preparing the IRB
application and prior to submitting the application to the IRB. Include legal counsel’s recommendations (legal counsel’s
recommendations may be attached in the E-IRB "Additional Information" section as a separate document, if necessary). For a
complete definition of emancipated minors, see the section on Emancipated Individuals in the Informed Consent SOP [PDF].
Informed Consent for Research Involving Non-English Speaking Subjects
If you are recruiting non-English speaking subjects, the method by which consent is obtained should be in language in which the
subject is proficient. Describe the process for obtaining informed consent from prospective subjects in their respective language (or
the legally authorized representative’s respective language). In order to ensure that individuals are appropriately informed about the
study when English is their second-language, describe a plan for evaluating the level of English comprehension, and the threshold for
providing a translation, or explain why an evaluation would not be necessary. For additional information on inclusion of non-English
speaking subjects, or subjects from a foreign culture, see Instructions for Recruiting Non-English Speaking Participants or Participants
from a Foreign Culture.
Research Repositories
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance regarding
consent issues, process approaches, and sample language see the “University of Kentucky Issues to be Addressed and Sample
Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use” [PDF].
Informed consent will be obtained at the Kentucky Neuroscience Institute Neuromuscular Laboratory from patients who have been
previously diagnosed with DMII and have had NCVs as standard-of-care and are interested in participating. Prior to entering the study,
the risks and benefits of participating will be explained to potential subjects. Patients will be given sufficient time to review and read
through the consent form and ask questions. All questions will be answered to the patients’ satisfaction. A copy of the signed
informed consent will be placed in each subject’s medical record. The original, signed informed consent form will be retained by the
investigator. The study subject will receive a copy of the informed consent form.
Back to Top
Research Procedures: Describe the research procedures that will be followed. Identify all procedures that will be carried out with
each group of subjects. Differentiate between procedures that involve standard/routine clinical care and those that will be performed
specifically for this research project.
After signing an IRB-approved informed consent, all research subjects will have: • skin biopsy, 3 mm in diameter, taken from volar
forearm using a standardized kit and vibratory sensation measured over the tip of the 2nd digit (index finger) quantified using a Rydel-
Seiffer 128 Hz tuning fork),. Skin biopsies will be collected and stored in formalin. • venipuncture for blood samples utilizing the UK
Healthcare Clinical Laboratories (total volume = 30-60 ml). Blood samples will be collected for measure of RBC amylin (performed in
Dr. Despa’s laboratory) and HbA1c (UK Healthcare Clinical Laboratories), as well as those measures not performed in the previous 6
months to include metabolic profile, complete blood count, vitamin B12, and thyroid stimulating hormone (UK Healthcare Clinical
Laboratories). • pain/sensory testing will be conducted (as described below) to assess sensory responses. Pain/Sensory Testing
Procedures: These assays have been safely implemented in our previous research studies (as indicated below) and are designed
not to cause and tissue damage. a. Pressure Algometer Test: The pressure algometer test will be conducted using a computerized
system (Medoc AlgoMed, U.S.A, Durham, N.C.). Pressure is applied at the rate of 40 kilopascals/sec with an algometer device will be
applied to the thenar eminence (the area just below the thumb) on the palm side of the dominant hand. Two trials will be conducted,
with at least 5 minutes separating each application. The main outcome measures for this test are 1) first detection of pressure
sensation (sensory threshold) and 2) first detection of a painful sensation (pain threshold) (measured in kPa). We have safely used
this procedure in previous studies (Protocols # 14-0769-F3R, 11-0816, 11-0980). b. Cold Pressor Test: Participants immerse their
non-dominant forearm in a warm water (room temperature) bath for a total of 2 minutes. After the 2 minutes is complete, the
participant is assisted in placing his/her forearm in a cold water bath (1.0°C ± 0.5°C) and is instructed to not touch the side or bottom
of the water bath. Participants will report when they begin to feel pain (pain threshold) and will remove their arm from the water when
they can no longer tolerate the pain (pain tolerance). Cold water immersion will last for a maximum of 5 min (a predetermined safety
cut-off to prevent numbness or tissue damage). Pain threshold and tolerance (seconds of immersion) will be recorded manually. Our
laboratory has previous experience safely using this procedure (IRB Protocols #14-0769-F3R , 06-0605, 11-0816, 11-0980). c. Cold
Thermode Testing: A thermode will be applied to on the dorsal surface of the hand. The temperatures will start at approximately room
temperature (approx. 35°C) and will steadily decrease (lowest possible temperature is 0° C). Volunteers will indicate when they begin
to feel a cold sensation (sensory threshold) and the thermode will be removed when the participant reports the sensation of pain (pain
threshold). If the participant does not report any pain, the thermode will be removed when the temperature reaches 0°C. Sensory and
pain threshold are the main outcome measures and will be measured in temperature (e.g., the temperature at which they begin to feel
Section 8 Page 4 of 9
42732

cold and the temperature at which they detect the pain). Our laboratory has previous experience safely using this procedure (IRB
Protocols #14-0769-F3R). d. Heat Thermode Test: A thermode will be applied to the skin of the arm. Thermode temperature will
begin at approximately room temperature (approx. 35°C) and will steadily increase (highest possible temperature is 53° C).
Volunteers will indicate when they begin to feel a hot sensation (sensory threshold) and the thermode will be removed when the
participant reports the detection of pain (pain threshold). If the participant does not report any pain during a given trial, the thermode
will be removed when the maximum temperature is reached (53° C). Two applications will be conducted during trial. Sensory and pain
thresholds are the main outcome measures and will be measured in temperature (e.g., the temperature at which they begin to feel a
hot sensation and the temperature at which they begin to feel pain).
Attachments
Data Collection: List the data or attach a list of the data to be collected about or from each subject (e.g. interview script, survey tool,
data collection form for existing data).
If the research includes survey or interview procedures, the questionnaire, interview questions or assessment scales should be
included in the application (use attachment button below).
The data collection instrument(s) can be submitted with your application in draft form with the understanding that the final copy will be
submitted to the IRB for approval prior to use (submit final version to the IRB for review as a modification request if initial IRB approval
was issued while the data collection instrument was in draft form).
The following data will be collected: • Results from relevant laboratory analyses • Results from sensory examination • Results from
peripheral nerve conduction velocities (NCVs) • Data from your medical record including duration of DMII diagnosis, current
medications, height and weight • No other areas will be examined
Attachments
Resources: Describe what resources/facilities are available to perform the research (i.e., staff, space, equipment). Such resources
may include a) staffing and personnel, in terms of availability, number, expertise, and experience; b) psychological, social, or medical
services, including counseling or social support services that may be required because of research participation; c) psychological,
social, or medical monitoring, ancillary care, equipment needed to protect subjects; d) resources for subject communication, such as
language translation services, and e) computer or other technological resources, mobile or otherwise, required or created during the
conduct of the research. Please note: Some mobile apps may be considered mobile medical devices under FDA regulations (see
FDA Guidance). Proximity or availability of other resources should also be taken into consideration, for example, the proximity of an
emergency facility for care of subject injury, or availability of psychological support after participation. 
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky, at sites that are
geographically separate from UK, or at sites that do not fall under the UK IRB’s authority, are subject to special procedures for
coordination of research review. Additional information is required (see ORI's Off-Site Research web page); supportive documentation
can be attached in the E-IRB "Additional Information" section. Provide a written description of the role of the non-UK site(s) or non-UK
personnel who will be participating in your research. The other site may need to complete its own IRB review, or a cooperative review
arrangement may need to be established. Contact the Office of Research Integrity at (859) 257-9428 if you have questions about the
participation of non-UK sites/personnel.
If the University of Kentucky is the lead site in a multi-site study, or the UK investigator is the lead investigator, describe the plan for
managing the reporting of unanticipated problems, noncompliance and submission of protocol modifications and interim results from
the non-UK sites.
Patient recruitment and consenting will be done at Kentucky Neuroscience Institute Neuromuscular Laboratory. Venipuncture for
RBCs and HgA1c utilizing the UK Healthcare Clinical Laboratories. Storage of RBCs and skin biopsies, as well as their analyses for
amylin, including all immunohistochemical staining and confocal-microscopic analysis will be done by Florin Despa, PhD (Co-
Investigator) at his lab located in Room 459, Charles T. Wethington Building. Pain testing sessions will occur at the Straus Behavioral
Science Building.
Potential Risks: Describe any potential risks or likely adverse effects of the drugs, biologics, devices or procedures subjects may
encounter while in the study. Please describe any physical, psychological, social, legal or other risks and assess their likelihood and
seriousness.
• Skin Biopsy: A skin biopsy is a generally safe procedure, but complications can occur, including bleeding, bruising, scarring and
rarely an infection. The site may be sore afterwards. If an infection does occur, it can be treated. • Venipuncture: The risks of having
blood drawn include slight pain, a bruise and/or bleeding at the site of the needle stick. Occasionally, a person may feel faint when
blood is drawn. The site may be sore afterwards. Rarely, an infection may develop. If an infection does occur, it can be treated. • Pain
Tests: The participants will feel acute painful sensations, but these resolve quickly and do not cause any tissue damage. Side effects
may include skin redness, tenderness and irritation,. Participants have safely tolerated the proposed pain tests in previous studies
and no serious adverse events have occurred (IRB Protocols #14-0769-F3R)
Back to Top
Section 8 Page 5 of 9
42732

Safety Precautions: Describe the procedures for protecting against or minimizing any potential risks, including risks of breach of
confidentiality or invasion of privacy. Where appropriate, discuss provisions for ensuring necessary medical or professional
intervention in the event of adverse events, or unanticipated problems involving subjects. Also, where appropriate, describe the
provisions for monitoring the data collected to ensure the safety of subjects. If vulnerable populations other than adults with impaired
consent capacity are to be recruited, describe additional safeguards for protecting the subjects’ rights and welfare.
There will be no interventions, no changes in medications, and no “safety” risks to subjects.
Benefit vs. Risk: Describe potential benefits to the subject(s); include potential benefits to society and/or general knowledge to be
gained. Describe why the risks to subjects are reasonable in relation to the anticipated benefit(s) to subjects and in relation to the
importance of the knowledge that may reasonably be expected to result. If you are using vulnerable subjects (e.g., impaired consent
capacity, pregnant women, etc…), justify their inclusion by describing the potential benefits of the research in comparison to the
subjects’ vulnerability and the risks to them.  For information about inclusion of certain vulnerable populations, see the IRB/ORI
Standard Operating Procedure for Protection of Vulnerable Subjects [C3.0100] [PDF].
Subjects may not receive any direct benefit from participating in this study. This pilot study will provide preliminary data to fuel a larger,
potentially multi-center, clinical trial investigating the utility of peripheral amylin or RBC amylin as a quantitative biomarker of
microvascular disease that would include monitoring the effect of potential therapies.
Available Alternative Treatment(s): Describe alternative treatments and procedures that might be advantageous to the subjects,
should they choose not to participate in the study. This should include a discussion of the current standard of care treatment(s).
Not Applicable
Back to Top
Research Materials, Records and Privacy: Identify the sources of research material obtained from individually identifiable living
human subjects. Indicate what information (specimens, records, data, genetic information, etc.) will be recorded and whether use will
be made of existing specimens, records or data. Explain why this information is needed to conduct the study.
Return of Research Results or Incidental Findings (if applicable):
If research has the potential to identify individual results or discover incidental findings that could affect the health of a subject,
describe plans to assess, manage, and if applicable disclose findings with individual subjects or provide justification for not disclosing.
For IRB expectations, refer to the UK IRB “Frequently Asked Questions (FAQs) on the Return of Research Results or Incidental
Research Findings” [PDF].
The investigative team maintains the right to keep, preserve, use and dispose of the findings of this investigation in accordance with
Health Insurance Portability and Accountability Act (HIPAA), and National Institute of Health (NIH) guidelines. The National Institute of
Health (NIH) maintains the right to inspect the records of the study at any time. Investigational records from this study will be
maintained in a confidential manner, subject names will not be associated with any published results.
Confidentiality: Specify where the data/specimens will be stored and how the researcher will protect both the data and/or specimens
with respect to privacy and confidentiality. Address physical security measures (e.g., locked facility, limited access); data security (e.g.,
password-protection, data encryption); safeguards to protect identifiable research information (e.g., coding, links, certificate of
confidentiality); and procedures employed when sharing material or data, (e.g., honest broker (if applicable), written agreement with
recipient not to re-identify). If you plan to procure, store, and/or share material (tissue/specimens/data) expressly for use in current or
future research, describe measures that you will take to secure and safeguard confidentiality and privacy.
Provide a time table for destroying the data/specimens and identify how they will be destroyed, or provide rationale for perpetual
maintenance [Note: The investigator is responsible for retaining the signed consent and assent documents and IRB research records
for at least six years after study closure as outlined in the Study Closure SOP [PDF]. If the research falls under the authority of FDA or
other regulatory agency, the investigator is responsible for retaining the signed documents and IRB records for the period specified if
longer than six years after completion of the study]. For multi-site studies, the PI consults the study sponsor regarding retention
requirements, but must maintain records for a minimum of six years after study closure. Also, specify who will access the identified
data/specimens, and why they need access. If applicable, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator. If applicable, describe procedures for sharing data/specimens with entities not affiliated with UK. 
NIH-funded genomic research: The National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy sets forth
expectations that ensure the broad and responsible sharing of genomic research data consistent with the informed consent
of study participants from which the data was obtained. If you are submitting genomic data to an NIH data repository,
describe your NIH data sharing plan.
Please note: The IRB expects researchers to access the minimal amount of identifiers to conduct the study and comply with
applicable HIPAA and Family Educational Rights and Privacy Act (FERPA) requirements. If data are going to be collected, transmitted,
and/or stored electronically, for appropriate procedures please refer to the guidance document "Confidentiality and Data Security
Guidelines for Electronic Data" [PDF].
Also please note that storage of data on cloud services may not be appropriate and is subject to applicable university policies
regarding the use of cloud services. If deemed too sensitive or inappropriate to be stored or collected using cloud services, the IRB
Section 8 Page 6 of 9
42732

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Does your research involve Non-English Speaking Subjects or Subjects from a Foreign Culture?
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if
necessary, how new information about the research may be relayed to subjects during the study.
Include contact information for someone who can act as a cultural consultant for your study.  The person should be familiar
with the culture of the subject population and/or be able to verify that translated documents are the equivalent of the
English version of documents submitted. The consultant should not have any direct involvement with the study. If you do
not know someone who would be willing to act as your cultural consultant, the Office of Research Integrity will try to find
someone to fill this role (this may delay the approval process for your protocol). Please include the name, address,
telephone number, and email of the person who will act as the cultural consultant for your study.  For more details, see
ORI’s help page on Research Involving Non-English Speaking Subjects or Subjects from a Foreign Culture.
For recruitment of Non-English speaking subjects, the consent document needs to be in the subject’s native language. 
Download the informed consent template available in the E-IRB "Informed Consent/Assent Process" section and use it as
a guide for developing the consent document. (Note: Your translated consent document can be attached to your
application in the “Informed Consent" section; be sure to save your responses in this section first.)
If research is to be conducted at an international location, identify local regulations, laws, or ethics review requirements for
human subject protection. If the project has been or will be reviewed by a local Ethics Committee, attach a copy of the
review to the UK IRB using the attachment button below. You may also consult the current edition of the International
Compilation of Human Research Standards
Section 8 Page 8 of 9
42732

Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s
summary sheet: “Reporting Requirements for Diseases and Conditions in Kentucky” [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for
obtaining informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the Medical IRB's requirements
for Protection of Human Subjects in Research Involving HIV Testing, and visit the Office for Human Research Protections
web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:                                                                                                                                                 
         Back to Top
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the PI assumes the regulatory responsibilities of both the investigator and sponsor. The Office
of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials, IDE regulatory
requirements for SR device trials, and abbreviated regulatory requirements for NSR device trials. For detailed descriptions see
FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-Investigators.
Describe your (the PI’s) experience/knowledge/training (if any) in serving as a sponsor (e.g., previously held an IND/IDE);
and
Indicate if you have transferred any sponsor obligations to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or
device) before final IRB approval is granted.
Has the PI completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If you (the PI) have completed equivalent sponsor-investigator training, you may submit documentation of the content for the
IRB’s consideration.
Attachments
Section 8 Page 9 of 9
42732

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Attachments
Section 10 Page 2 of 2
42732

STUDY DEVICE INFORMATION
A DEVICE may be a:
component, part, accessory;
assay, reagent;
software or computer/phone application;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE)
or Humanitarian Device Exemption (HDE) application? See UK HUD SOP [PDF] for guidance.
Yes
No
If Yes, list IDE or HDE #(s) and complete the following:
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment or Compassionate Use IDE under the Food and Drug Administration
(FDA) Early Expanded Access program.
FDA's Early Expanded Access Program Information
Guidance and definitions: "Medical Device Clinical Investigations, Compassionate Use, and
Treatment IDE SOP" [PDF]
Does the intended use of any device used in this study meet the regulatory definition of Significant Risk (SR) device?
Yes. Device(s) as used in this study presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is
intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing,
curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential
Section 11 Page 1 of 2
42732

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List all other non-UK owned/operated locations
where the research will be conducted:*
*A letter of support and local context is required from
non-UK sites. Click HERE for more information.
RESEARCH SITES
In order for this section to be considered complete, you must click "SAVE" after ensuring all responses are accurate.
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's Off-site Research Instructions
web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Attachments
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes
No
If YES, you must describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of
protocol modifications and interim results from the non-UK sites in the E-IRB "Research Description" section under Resources.
Section 12 Page 1 of 2
42732

If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and university requirements which
need to be completed for their participation, such as the establishment of a cooperative IRB review agreement with the non-UK site.
Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-9428.
Section 12 Page 2 of 2
42732

RESEARCH ATTRIBUTES
Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Aging Research
Alcohol Abuse Research
Cancer Research
Certificate of Confidentiality
CCTS-Center for Clinical & Translational Science
Clinical Research
Clinical Trial
Clinical Trial Multicenter(excluding NIH Cooperative Groups)
Clinical Trial NIH cooperative groups (i.e., SWOG, RTOG)
Clinical Trial Placebo Controlled Trial
Clinical Trial UK Only
Collection of Biological Specimens
Collection of Biological Specimens for Banking
Community-Based Participatory Research
Data & Safety Monitoring Board
Data & Safety Monitoring Plan
Deception
Drug/Substance Abuse Research
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Genetic Research
Gene Transfer
GWAS (Genome-Wide Association Study) or NIH-funded study
generating large scale genomic data
International Research
Internet Research
Planned Emergency Research Involving Waiver of Informed
Consent
Pluripotent Stem Cell Research
Recombinant DNA
Survey Research
Transplants
Use of radioactive material, ionizing radiation, or x-rays [Radiation
Safety Committee review required]
Vaccine Trials
Click applicable listing(s) for additional
requirements and/or information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality 
CCTS (Center for Clinical and Translational
Science)
Clinical Research 
Clinical Trial 
*Reminder: Ensure compliance with
clinicaltrials.gov registration requirements for
applicable clinical trials
Collection of Biological Specimens for Banking 
Collection of Biological Specimens 
Community-Based Participatory Research 
Data & Safety Monitoring Board
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the
Informed Consent section, checkmark and
complete "Request for Waiver of Informed
Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist]
Genetic Research 
Gene Transfer
HIV/AIDS Research 
Screening for Reportable Diseases [E2.0000]
International Research 
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the
Informed Consent section, checkmark and
complete "Request for Waiver of Informed
Consent Process"
Use of radioactive material, ionizing radiation or
x-rays for research
Section 13 Page 1 of 1
42732

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the DoD SOP.
DOD SOP Attachments
Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration
of Exemption form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Section 14 Page 2 of 2
42732

OTHER REVIEW COMMITTEES
If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC)--Attach required IBC
materials
Radiation Safety Committee (RSC)-- For applicability, see
instructions and/or upload form [WORD] [RTF]
Radioactive Drug Research Committee (RDRC)--information
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)**--Attach MCC PRMC materials, if any, per
instructions
See requirement of Office of Medical Education (OME)
See requirement of Graduate Medical Education Committee
(GME)
Attachments 
** If you are proposing a study involving cancer research, be sure to have "Cancer Research" marked in the E-
IRB "Research Attributes" section. If your study involves cancer research, ORI will provide a copy of your research
protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring Committee (PRMC). The MCC PRMC is
responsible for determining whether the study meets the National Cancer Institute (NCI) definition of a clinical trial and for
issuing documentation to you (the investigator) which confirms either that PRMC approval has been obtained or that PRC
review is not required. Your IRB application will be processed and reviewed independently from the PRMC review.
Section 15 Page 1 of 1
42732

ADDITIONAL INFORMATION/MATERIALS
Do you want specific information inserted into your approval letter?
Yes
No
Approval Letter Details (e.g., serial #):
Submission Description: If you wish to have specific details included in your approval letter (e.g., serial #, internal tracking
identifier, etc…), provide that information here as you wish it to be seen on the approval letter. These details will be automatically
merged into a field at the top of the approval letter when it is generated. If these details need to be changed as a result of
revisions or modifications to the application, you are responsible for updating the content of the field below accordingly.
Protocol/Product Attachments - For each item checked, please attach the corresponding material.
Detailed protocol
Dept. of Health & Human Services (DHHS) approved protocol (such as NIH sponsored Cooperative Group Clinical Trial)
Drug Documentation (e.g., Investigator Brochure; approved labeling; publication; FDA correspondence, etc.)
Device Documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA correspondence,
etc.)
Other Documents
Protocol/Product Attachments
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol [HTML]
If you have password protected documents, that feature should be disabled prior to uploading to ensure access
for IRB review.
Additional Materials:
If you have other materials you would like to include in your application for the IRB’s consideration, please attach using the Attachments
button below.
[To view what materials are currently attached to your application, go to “Application Links” in the menu bar on the left and click “All
Attachments”.]
Attachments
Attach Type
File Name
AdditionInfoConsiderations McGill Questionaire.pdf
AdditionInfoConsiderations Protocol Sheets_.xls
AdditionInfoConsiderations Online_Deviation_ViewReportable.pdf
AdditionInfoConsiderations DMII_Amylin-Research_Grant_References_09-20-2017.pdf
AdditionInfoConsiderations 42732_DEVIATION_APPROVAL_LETTER_ID _ 218__11-29-2017.pdf
Section 16 Page 1 of 1
42732

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Section 17 Page 2 of 2
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Document Type
File Loaded
Document Description
File
Size
Modified
By
Mod
Date
Stamped Consent Form
IRB Memo Amylin Study.pdf
 
0.079 jlkear0
1/25/2018
10:31:51
AM
Stamped Consent Form
IRB Memo Amylin Study Modification #2.pdf
 
0.064 jlkear0
1/25/2018
10:31:51
AM
Stamped Consent Form
Clean_DMII_Amylin-
Form_C_Med_and_HIPAA_1.5.2018.....pdf
 
0.101 jlkear0
1/25/2018
10:31:51
AM
Stamped Consent Form
IRB Memo Amylin Study Modification #3 SP
Add Alcala.pdf
 
0.060 jlkear0
1/25/2018
10:31:51
AM
ApprovalLetter
ApprovalLetter.pdf
 
0.057 jlkear0
1/25/2018
10:31:50
AM
CoverLetter
IRB Memo Amylin Study Modification #3 SP
Add Alcala.pdf
Cover Memo SN#03 SP Add Alcala
0.048 samo222
1/24/2018
3:58:11
PM
AdditionInfoConsiderations
42732_DEVIATION_APPROVAL_LETTER_ID
_ 218__11-29-2017.pdf
Deviation Approval Letter
0.058 samo222
1/11/2018
12:02:22
PM
Informed ConsentHIPAA Combined
Form
Clean_DMII_Amylin-
Form_C_Med_and_HIPAA_1.5.2018.....pdf
Clean_DMII_Amylin_Form_C_and_HIPAA__1.5.2018 0.059 samo222
1/11/2018
10:57:29
AM
InformedConsent_HighlightedChanges Tracked_DMII_Amylin-
Form_C_Med_and_HIPAA_1.5.2018.pdf
Tracked_DMII_Amylin-Form_C_Med_and_HIPAA
0.071 samo222
1/11/2018
10:51:37
AM
GrantContract
DMII_Amylin-
Research_Grant_References_09-20-2017.pdf
DMII_Amylin-
Research_Grant_References_09_20_2017
0.085 samo222
1/10/2018
12:12:50
PM
CoverLetter
IRB Memo Amylin Study.pdf
Cover Memo
0.060 samo222
1/10/2018
12:07:21
PM
GrantContract
Slevin Neurology Research Proposal v2.pdf
DMII_Amylin-Slevin Neurology Research Proposal v2
0.128 samo222
1/10/2018
11:40:07
AM
AdditionInfoConsiderations
DMII_Amylin-
Research_Grant_References_09-20-2017.pdf
DMII_Amylin-Research_Grant_References_09-20-
2017
0.085 samo222
1/10/2018
11:39:28
AM
AdditionInfoConsiderations
Online_Deviation_ViewReportable.pdf
42732 Protocol Deviation Information
0.073 samo222
1/10/2018
11:37:53
AM
AdditionInfoConsiderations
Protocol Sheets_.xls
Protocol Sheets
0.095 samo222
1/5/2018
9:28:41
AM
AdditionInfoConsiderations
McGill Questionaire.pdf
Patient Questionnaire
0.088 samo222
1/5/2018
9:28:23
AM
CoverLetter
IRB Memo Amylin Study Modification #2.pdf
Cover Memo Modification #2
0.050 samo222
1/5/2018
9:24:48
AM
Section 19 Page 1 of 1
42732

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Section 21 Page 1 of 1
42732