TrialGlobe

Clinical trial

Insulin Regulation of Lipolysis and Lipolysis Proteins

Recruiting now · Early Phase 1 · 1 countries · Registry ID NCT03866408

Recruiting nowEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionObesity

Full registry 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.

Treatments and study arms

Immediate weight loss

Behavioral

Upper body obese subjects will undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.

Pioglitazone

Drug

Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.

Deferred weight loss

Behavioral

Upper body obese subjects will complete a weight-stable period of 4 months and subsequently undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.

Placebo

Drug

Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mayo Clinic in Rochester🇺🇸 Rochester, Minnesota, United States
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Pamela A ReichContact
Email · Call 507-255-6062