Understanding how insulin affects fat breakdown in people with obesity
Insulin Regulation of Lipolysis and Lipolysis Proteins
This study is testing how insulin affects fat breakdown in people with obesity and whether a diabetes medication can help improve this process.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03866408 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the abnormalities in proteins within fat cells that contribute to the inability of insulin to effectively suppress fat breakdown in individuals with upper body obesity. Researchers will assess the relationship between insulin-induced suppression of lipolysis and specific lipolysis proteins in volunteers with varying abdominal fat sizes. Additionally, the study will explore how the medication pioglitazone, which is used to treat type 2 diabetes, influences insulin regulation of fat metabolism, both with and without weight loss.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 55, including premenopausal women, with a BMI between 18-25 for non-obese individuals or 30-38 for obese individuals.
Not a fit: Patients with established heart failure or known hypersensitivity to pioglitazone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for obesity and better management of insulin resistance.
How similar studies have performed: Other studies have shown promise in understanding insulin regulation and fat metabolism, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and Women between the ages of 18 and 55. * Women will be premenopausal * Non obese adults BMI between 18-25 * Obese BMI 30-38 Exclusion Criteria, Pioglitazone package insert of contraindications for use: * Initiation in patients with established New York Heart Associations (NYHA) class III or IV Heart failure. * Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOSE.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Jensen — Mayo Clinic
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.