A Causative Role for Amylin in Diabetic Peripheral Neuropathy

NCT03481283 | Recruiting

• 1 other identifier: 42732
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Three pieces of information lead to the basis for this study:

1. 1.Individuals with Type-2 diabetes commonly develop peripheral neuropathy.
2. 2.Increased production of the hormone amylin occurs in individuals who have Type-2 diabetes.
3. 3.Aggregations of amylin was found in the peripheral vasculature of rats that overexpressed human amylin.

Conditions

Type2 Diabetes; Peripheral Neuropathy

Keywords

Amylin

Outcome Measures

Primary Outcomes (2)

• 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.

  Single time point. Blood sample will be obtained from patient participant immediately after nerve conduction studies are performed.

• 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.

  Single time point. Skin biopsy will be obtained from patient participant immediately after nerve conduction studies are performed.

Secondary Outcomes (3)

• Pressure pain threshold vs RBC amylin and blood vessel wall amylin deposition

  Participants will undergo pressure test 1 week after providing blood and skin biopsy

• Cold pressor test vs RBC amylin and blood vessel wall amylin deposition

  Participants will undergo cold pressor test 1 week after providing blood and skin biopsy

• Heat thermode test vs RBC amylin and blood vessel wall amylin deposition

  Participants will undergo heat thermode test 1 week after providing blood and skin biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Subject has been diagnosed with Type-2 Diabetes.
• Subject shows mild-to-severe peripheral neuropathy, as determined by Nerve Conduction Velocity (NCV) tests.

You may not qualify if:

• Subject has not been diagnosed with Type-2 Diabetes.
• Subject shows average, or above average performance on Nerve Conduction Velocity (NCV) tests.

Sponsors & Collaborators

• Zabeen Mahuwala, MD: lead

Study Sites (2)

UK Robert Straus Behavioral Science Laboratory

Lexington, Kentucky, 40508, United States

ACTIVE NOT RECRUITING

University of Kentucky - Kentucky Neuroscience Institute

Lexington, Kentucky, 40536, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Obtaining blood samples and skin biopsy samples to measure amount of amylin present in those tissues.

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• John T Slevin, M.D., M.B.A.

  University of Kentucky Department of Neurology

  PRINCIPAL INVESTIGATOR

• Zabeen Mahuwala, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rani Priyanka Vasireddy, MBBS, MHA

CONTACT

859-218-5076; rvasireddy@uky.edu

John T Slevin, M.D., M.B.A.

CONTACT

8593236702; jslevin@email.uky.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 29, 2018
• Study Start: February 5, 2018
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)