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Observational Study on Amylin and Diabetic Peripheral Neuropathy

This study is looking into whether a hormone called amylin plays a role in diabetic peripheral neuropathy (nerve damage in your hands and feet). People with Type 2 diabetes often develop this nerve damage and also produce more amylin. Researchers have also seen amylin buildup in blood vessels of animals. This study wants to see if there's a connection between the amount of amylin in your upper body and how severe your peripheral neuropathy is. You may be able to join if you have Type 2 diabetes and mild-to-severe peripheral neuropathy, as shown by nerve conduction tests. The study is trying to understand if amylin contributes to this nerve damage.

Study design
This is an observational study planning to include 40 participants. It is not specified if it is randomized or blinded.
What's involved
You would have a blood sample taken and a skin biopsy performed immediately after nerve conduction studies.
Compensation
Not stated in the trial record.
Follow-up
Your amylin levels and neuropathy severity will be measured at a single time point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03481283

A Causative Role for Amylin in Diabetic Peripheral Neuropathy

Recruiting
Not specifiedAges 18+Observational
Zabeen Mahuwala, MD
~40 participants
Updated 2026-01-30 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Red blood cell amylin level vs severity of peripheral neuropathy
Measured over Single time point. Blood sample will be obtained from patient participant immediately after nerve conduction studies are performed.
+1 more outcome measured

Conditions

Type2 Diabetes
Peripheral Neuropathy

Explore related trials

Peripheral NeuropathyType 2 Diabetes Mellitus

Where it's being run

2 sites across 1 states
Kentucky2

Study leadership

  • John T Slevin, M.D., M.B.A. · PRINCIPAL_INVESTIGATOR · University of Kentucky Department of Neurology
  • Zabeen Mahuwala, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Rani Priyanka Vasireddy, MBBS, MHA
[email protected]
859-218-5076
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Red blood cell amylin level vs severity of peripheral neuropathySingle time point. Blood sample will be obtained from patient participant immediately after nerve conduction studies are performed.

    RBCs will be harvested from whole blood samples of participants and quantified RBC-bound amylin will be correlated with severity of nerve conduction velocities.

  • Blood vessel wall amylin deposition vs severity of peripheral neuropathySingle time point. Skin biopsy will be obtained from patient participant immediately after nerve conduction studies are performed.

    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.