Recruiting

Amylin

Sponsor:

Zabeen Mahuwala, MD

Code:

NCT03481283

Conditions

Type2 Diabetes

Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Type2 Diabetes

Peripheral Neuropathy

Study ID

NCT03481283

Start date

Feb 5, 2018

Status verified date

Jan, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Red blood cell amylin level vs severity of peripheral neuropathy [ Time Frame: 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 [ Time Frame: Single time point. Skin biopsy will be obtained from patient participant immediately after nerve conduction studies are performed. ]

Central Contacts and Locations

Central contacts

Rani Priyanka Vasireddy, MBBS, MHA

859-218-5076rvasireddy@uky.edu

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

8593236702jslevin@email.uky.edu

Locations

University of Kentucky - Kentucky Neuroscience Institute

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Rani Priyanka Vasireddy, MBBS, MHA

859-218-5076rvasireddy@uky.edu

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

8593236702jslevin@email.uky.edu

Principal Investigator:

John T Slevin, MD, Ph.D.

More Information

Sponsor

Zabeen Mahuwala, MD

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Amylin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zabeen Mahuwala, MD on 2026-01-30.