Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT05593549

Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

Led by Medical College of Wisconsin · Updated on 2025-10-30

60

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to examine the role of autophagy on microvascular function in adults with Type 2 Diabetes. The main question it aims to answer are: * Does presence of Type 2 Diabetes reduce autophagy and impair microvascular function? * Does exposure to high glucose impair autophagy and subsequently microvascular function? Participants will undergo 2 study days. The primary outcome will be in vivo microvascular function testing. Following the first study day participants will undergo either supplementation with trehalose, an autophagy activator, or placebo for 14 days. The second study day will test in vivo microvascular function.

CONDITIONS

Official Title

Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be between 18 and 80 years old
  • Have a clinical diagnosis of Type 2 Diabetes Mellitus according to American Diabetes Association guidelines or be otherwise healthy with no more than one cardiovascular risk factor
Not Eligible

You will not qualify if you...

  • Uncontrolled hypertension
  • Current tobacco use or tobacco use within the last 6 months
  • Body mass index (BMI) greater than 35
  • Hyperlipidemia or hypercholesterolemia
  • Diagnosis of Type 1 Diabetes
  • Use of anti-coagulant or anti-platelet drugs
  • Symptomatic coronary artery disease
  • Heart failure
  • Renal impairment
  • Use of hormone replacement therapy
  • History of retinopathy
  • Documented neuromuscular disorders
  • Porphyria Cutanea Tarda (skin blistering and photosensitivity)
  • Pregnancy (in young female subjects)
  • Allergies to povidone iodine
  • Use of erectile dysfunction medication in the past 6 months
  • Use of topical or non-topical steroids in the last 6 months
  • Active anti-cancer treatment or treatment within the last 12 months
  • Active COVID-19 or COVID-19 within the past 3 months
  • Gender reassignment therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

W

William Hughes, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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