Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05593549
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Trehalose — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226
William Hughes, Ph.D.
[email protected]

Find similar trials in Milwaukee, WI

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Medical College of Wisconsin· Milwaukee, WI

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