NCT05593549 · Medical College of Wisconsin
Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 30, 2025 · Source of record for eligibility and locations