Insulin Regulation of Lipolysis and Lipolysis Proteins in Obesity

This study is looking at how insulin controls fat breakdown (lipolysis) in people with obesity, specifically those with extra fat around their upper body. Researchers want to understand why insulin doesn't always work as well in these individuals and how a medication called pioglitazone, which is used for type 2 diabetes, might help. You could be eligible if you are between 18 and 55 years old, premenopausal if female, and have a BMI (Body Mass Index) between 18-25 (non-obese) or 30-38 (obese). The study will compare pioglitazone to a placebo (an inactive pill) and also look at the effects of weight loss through a behavioral program. Success would mean understanding how pioglitazone or weight loss changes specific proteins in fat cells to improve insulin's control over fat metabolism. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 64 participants. Participants will be randomly assigned to receive either pioglitazone or a placebo, and some will also participate in a weight loss program.
What's involved
Participants will undergo a behavioral intervention with a life coach and a physical activity program for 4 months, either immediately or after a 4-month stable period. The study will measure adipocyte (fat cell) responses to insulin between 4 and 9 months.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, which involve measuring fat cell responses to insulin, will be assessed between 4 and 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03866408

Insulin Regulation of Lipolysis and Lipolysis Proteins

Recruiting
EARLY_PHASE1Ages 18–55InterventionalBasic science
Mayo Clinic
~64 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Immediate weight lossPioglitazoneDeferred weight lossPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adipocyte response to insulin - perilipin 1 and FSP27 relative to HSL and ATGL
Measured over 4-9 months
+3 more outcomes measured
Obesity
1 sites across 1 states
Minnesota1
  • Michael D Jensen · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.
  • Adipocyte response to insulin - perilipin 1 and FSP27 relative to HSL and ATGL4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte perilipin 1 and FSP27 relative to HSL and ATGL.

  • Adipocyte response to insulin - adipocyte G0S2 relative to ATGL.4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte G0S2 relative to ATGL.

  • Adipocyte response to insulin - adipocyte CGI-58 relative to ATGL4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte CGI-58 relative to ATGL.

  • Adipocyte response to insulin - perilipin 1, ATGL and HSL phosphorylation4-9 months

    In response to weight maintenance vs. weight loss with pioglitazone vs. placebo, insulin regulation of lipolysis in upper body obese as measured by insulin IC50 for palmitate flux and compared to adipocyte perilipin 1, ATGL and HSL phosphorylation in response to insulin.