A Causative Role for Amylin in Diabetic Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZabeen Mahuwala, MD
About this trial
Three pieces of information lead to the basis for this study:
1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy. 2. Increased production of the hormone amylin occurs in individuals who have Type-2 diabetes. 3. Aggregations of amylin was found in the peripheral vasculature of rats that overexpressed human amylin.
The purpose of this study is to determine whether a correlation exists between the amount of amylin present in the upper extremities of human subjects with Type-2 diabetes and the extent to which symptoms of peripheral neuropathy are expressed in those subjects. The investigators will be testing this by initially collecting blood and skin biopsy samples from subjects, followed by measuring patient sensation and pain responses to heat, cold, and pressure in the upper extremities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has been diagnosed with Type-2 Diabetes.
Subject shows mild-to-severe peripheral neuropathy, as determined by Nerve Conduction Velocity (NCV) tests.
Disqualifiers
Subject has not been diagnosed with Type-2 Diabetes.
Subject shows average, or above average performance on Nerve Conduction Velocity (NCV) tests.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Red blood cell amylin level vs severity of peripheral neuropathy
RBCs will be harvested from whole blood samples of participants and quantified RBC-bound amylin will be correlated with severity of nerve conduction velocities.
Time frame
Single time point. Blood sample will be obtained from patient participant immediately after nerve conduction studies are performed.2
Blood vessel wall amylin deposition vs severity of peripheral neuropathy
A formalin-fixed 3 mm skin biopsy will be sectioned and stained with an anti-amylin antibody. Level of amylin deposition in blood vessel walls will be correlated with severity of peripheral neuropathy.
Time frame
Single time point. Skin biopsy will be obtained from patient participant immediately after nerve conduction studies are performed.Secondary outcomes
1
Pressure pain threshold vs RBC amylin and blood vessel wall amylin deposition
Participants' quantified pain threshold to applied pressure over the thenar eminence using a pressure algometer will be correlated to both RBC amylin and blood vessel wall amylin deposition.
Time frame
Participants will undergo pressure test 1 week after providing blood and skin biopsy2
Cold pressor test vs RBC amylin and blood vessel wall amylin deposition
Participants' quantified pain threshold to a cold water bath (1 deg C) emmersion of their non-dominant forearm will be correlated to both RBC amylin and blood vessel wall amylin deposition.
Time frame
Participants will undergo cold pressor test 1 week after providing blood and skin biopsy3
Heat thermode test vs RBC amylin and blood vessel wall amylin deposition
Participants' quantified pain threshold to a thermode placed on the dominant forearm will be correlated to both RBC amylin and blood vessel wall amylin deposition.
Time frame
Participants will undergo heat thermode test 1 week after providing blood and skin biopsySponsors and contacts
Click on the lead sponsor to view all of their trials.
Zabeen Mahuwala, MD
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov