Examining how autophagy affects blood vessel function in Type 2 Diabetes
Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction
EARLY_PHASE1 · Medical College of Wisconsin · NCT05593549
This study is testing if a supplement that boosts a process called autophagy can improve blood vessel function in adults with Type 2 Diabetes.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin (other) |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05593549 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with a clinical diagnosis of Type 2 Diabetes or otherwise healthy individuals with minimal cardiovascular risk factors.
Not a fit: Patients with uncontrolled hypertension, significant cardiovascular disease, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for improving microvascular function in patients with Type 2 Diabetes.
How similar studies have performed: While the role of autophagy in vascular health is being explored, this specific approach in the context of Type 2 Diabetes and microvascular function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Healthy Aging, autophagy, microvascular function, laser doppler microdialysis