Recruiting
Early Phase 1

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT05593549

Conditions

Type 2 Diabetes

Healthy Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Trehalose

Placebo

Study Details

Brief summary:

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

Type 2 Diabetes

Healthy Aging

Study ID

NCT05593549

Start date

Jan 1, 2023

Status verified date

Oct, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria: Participants must be between 18-80 yrs. of age and will be delineated into two groups

  • Clinical Diagnosis of Type 2 Diabetes Mellitus in accordance with American Diabetes Association (ADA) guidelines (Type 2 Diabetic group)
  • Otherwise healthy individuals (Healthy control group) with no more than 1 cardiovascular risk factor

Exclusion Criteria:

  • Uncontrolled hypertension
  • Current Tobacco use or within last 6 months
  • BMI > 35
  • Hyperlipidemia
  • Hypercholesterolemia
  • Type 1 Diabetes
  • Use of anti-coagulant drugs, or anti-platelet drugs
  • Symptomatic coronary artery disease
  • Heart Failure
  • Renal Impairment
  • Hormone Replacement Therapy
  • History of Retinopathy
  • Documented Neuromuscular Disorders
  • Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
  • Pregnancy (Young Female subjects)
  • Allergies to Povidone Iodine
  • Use Erectile Dysfunction Medication in the past 6 months
  • Use of Topical/non-topical Steroids in last 6 months
  • Active Anti-Cancer Treatment or Treatment within last 12 months
  • Active COVID-19 or within the past 3 months
  • Gender Reassignment Therapy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Trehalose

10g mixed in 500 mL of water, consumed 1 time per day

placebo comparator: Placebo

10g microcrystalline cellulose in 500 mL, consumed 1 time per day

Interventions

Trehalose

Trehalose will be given at a dose of 10g mixed in 500 mL of water to be consumed 1 time per day for 14 days

Placebo

Microcrystalline cellulose will be given at a dose of 10g mixed in 500 mL of water to be consumed 1 time per day for 14 days

Primary outcome measure

  • Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis [ Time Frame: 2 weeks ]
  • Autophagic Flux Protein Expression [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

William Hughes, Ph.D.

414-955-7519whughes@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

William Hughes, Ph.D.

whughes@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • autophagy
  • microvascular function
  • laser doppler microdialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-10-30.