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Studying Trehalose for Microvascular Dysfunction in Type 2 Diabetes

This study is looking at how a process called autophagy (where your body cleans out damaged cells) affects small blood vessel function in people with Type 2 Diabetes. Researchers want to see if Type 2 Diabetes reduces autophagy and harms these blood vessels, and if high blood sugar has a similar effect. You would receive either Trehalose, a drug that activates autophagy, or a placebo (an inactive substance like microcrystalline cellulose) for 14 days. The main goal is to measure how well your small blood vessels are working after this period. The study is currently unclear on its recruitment status and plans to enroll 60 participants aged 18 to 80, including those with Type 2 Diabetes and healthy individuals.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.
What's involved
You would participate in two study days, with 14 days of taking either Trehalose or placebo in between.
Compensation
Not stated in the trial record.
Follow-up
Your microvascular function will be measured at 2 weeks after starting the intervention.

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

NCT05593549

Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

Recruiting
EARLY_PHASE1Ages 18–80InterventionalBasic science
Medical College of Wisconsin
~60 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:TrehalosePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis
Measured over 2 weeks
+1 more outcome measured

Conditions

Type 2 Diabetes
Healthy Aging

Explore related trials

Healthy AgingType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • William Hughes, Ph.D. · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

William Hughes, Ph.D.
[email protected]
414-955-7519
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis2 weeks

    Cutaneous microvascular function measured via laser Doppler flowmetry coupled with intradermal microdialysis of non-specific nitric oxide synthase inhibitor, L-NAME

  • Autophagic Flux Protein Expression2 weeks

    Autophagic Flux protein expression in Peripheral Blood Mononuclear Cells (PBMC) will be measured via exogenous treatment of PBMCs with a lysosomal inhibitor and then expression of autophagic markers will be assessed via Western Blot.