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Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

RECRUITINGEarly 1Sponsored by Medical College of Wisconsin
Actively Recruiting
PhaseEarly 1
SponsorMedical College of Wisconsin
Started2023-01-01
Est. completion2028-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years – 80 YearsHealthy 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

Conditions3

DiabetesHealthy AgingType 2 Diabetes

Locations1 site

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
William Hughes, Ph.D.whughes@mcw.edu

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