Pioglitazone for Obesity
Trial Summary
What is the purpose of this trial?
These studies will define the abnormalities in the adipocyte proteins that are involved in the failure of insulin to suppress lipolysis normally in humans with upper body obesity and will help discover the mechanism by which pioglitazone, a medication used to treat type 2 diabetes and improve insulin resistance, improves insulin-regulation of adipocyte fatty acid metabolism.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Pioglitazone for obesity?
Is pioglitazone safe for humans?
Pioglitazone has been generally well tolerated in clinical trials, with common side effects including weight gain and swelling. However, it has been associated with an increased risk of bladder cancer, heart failure, and bone fractures in postmenopausal women. It is important to weigh these risks against the benefits when considering its use.16789
How does the drug pioglitazone differ from other treatments for obesity?
Pioglitazone is unique because it is primarily used to treat type 2 diabetes by improving insulin sensitivity, which may indirectly affect weight. Unlike other obesity treatments, it works by altering gene expression to reduce insulin resistance, potentially offering a novel approach to managing obesity.13101112
Research Team
Michael D Jensen
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for men and women aged 18-55, including premenopausal women. It's suitable for non-obese adults with a BMI of 18-25 and obese individuals with a BMI of 30-38. People allergic to pioglitazone or with severe heart failure (NYHA class III/IV) cannot participate.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Studies
Participants undergo baseline studies to assess initial conditions and measurements
Deferred Control Group - Placebo
Participants wait without any intervention for 4 months, with continued monitoring to assure weight stability
Immediate Weight Loss - Placebo
Participants begin immediate participation in a comprehensive lifestyle obesity treatment program
Deferred Group - Pioglitazone
Participants wait without any intervention for 4 months, monitored to prevent weight gain, while on pioglitazone
Immediate Weight Loss - Pioglitazone
Participants begin immediate participation in a comprehensive lifestyle obesity treatment program with pioglitazone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Deferred weight loss (Behavioral Intervention)
- Immediate weight loss (Behavioral Intervention)
- Pioglitazone (Thiazolidinedione)
- Placebo (Drug)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator