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RECRUITINGEarly Phase 1INTERVENTIONAL

Insulin Regulation of Lipolysis and Lipolysis Proteins

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 Being Tested

BEHAVIORAL

Immediate weight loss

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

DRUG

Pioglitazone

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

BEHAVIORAL

Deferred weight loss

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.

DRUG

Placebo

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

Locations (1)

Mayo Clinic in Rochester
Rochester, Minnesota, United States