Autophagy Activator for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how autophagy, the body's process for cleaning out damaged cells, affects blood vessel health in people with Type 2 Diabetes. Participants will take either trehalose, a sugar that might boost autophagy, or a placebo. Researchers will then assess the impact on blood vessels. The trial is open to individuals with Type 2 Diabetes and healthy participants with no more than one heart risk factor. As an Early Phase 1 trial, this research aims to understand how trehalose works in people, offering participants a chance to contribute to groundbreaking science.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain drugs like anti-coagulants, anti-platelet drugs, or steroids. It's best to discuss your specific medications with the trial coordinators.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that trehalose, the treatment being tested in this trial, is generally safe for people. In previous studies, participants took trehalose for up to 12 weeks without significant side effects. Even when consumed in large amounts in diets, no consistent or dose-related negative effects were reported, indicating that trehalose is well-tolerated. Additionally, it has been found to improve how the body handles sugar, benefiting those at risk of type 2 diabetes. Overall, trehalose appears to be a safe choice for this trial.12345
Why do researchers think this study treatment might be promising for Type 2 Diabetes?
Researchers are excited about Trehalose as a treatment for Type 2 Diabetes because it works by activating autophagy, a natural process that helps clean out damaged cells and regenerate healthier ones. Unlike current treatments such as metformin or insulin, which primarily focus on controlling blood sugar levels, Trehalose targets cell maintenance and health at a deeper cellular level. This novel mechanism could offer a fresh approach to managing the disease, potentially improving outcomes for patients by addressing underlying cellular dysfunctions.
What evidence suggests that trehalose might be an effective treatment for Type 2 Diabetes?
Research has shown that trehalose, a natural sugar, might help control blood sugar levels, particularly for those at risk of type 2 diabetes. In earlier studies, participants who consumed trehalose daily for 12 weeks demonstrated better glucose tolerance, meaning their bodies managed sugar more effectively. Other studies found that trehalose helped prevent weight gain and improved insulin efficiency in lowering blood sugar. Animal studies also showed that trehalose could prevent some symptoms of metabolic disorders, such as difficulty managing sugar levels. Overall, these findings suggest that trehalose might aid in managing blood sugar and related issues. In this trial, participants will receive either trehalose or a placebo to evaluate its effectiveness in managing type 2 diabetes.15678
Who Is on the Research Team?
William Hughes, Ph.D.
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Adults aged 18-80 with Type 2 Diabetes as per ADA guidelines or healthy individuals with no more than one cardiovascular risk factor can join. Exclusions include those on erectile dysfunction meds, steroids, or hormone therapies recently; heart failure patients; BMI over 35; tobacco users in the last six months; and several other conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either trehalose or placebo for 14 days to assess the role of autophagy in microvascular function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Trehalose
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor