Examining how autophagy affects blood vessel function in Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of autophagy on microvascular function in adults with Type 2 Diabetes. Participants will undergo two study days, where the first day will assess their microvascular function, followed by a 14-day supplementation period with either trehalose, an autophagy activator, or a placebo. The second study day will again evaluate microvascular function to determine the effects of the intervention. The study aims to clarify whether Type 2 Diabetes impairs autophagy and subsequently affects microvascular health.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: William Hughes, Ph.D. — Medical College of Wisconsin
• Study coordinator: William Hughes, Ph.D.
• Email: whughes@mcw.edu
• Phone: 414-955-7519

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.