Condition(s) treated: Insulin Resistance; Obesity; Metabolic Syndrome

Intervention: weight loss (Behavior); thiazolidinedione (Drug)

Phase: Phase 4

Enrollment status: Recruiting. Expecting to enroll 100 people.

Sponsor: Stanford University

Principal investigator(s) or official(s):
Tracey McLaughlin, MD, MS, Study Director, Affiliation: Stanford University

Overall contact:
Tracey McLaughlin, MD, MS, Phone: 650-723-7024

The goal of this study is to determine why some obese individuals develop insulin resistance and others do not. We hypothesize that an impairment in differentiation of fat cells (adipocytes) is responsible for the development of insulin resistance in select obese individuals. This study will evaluate obese individuals at baseline with respect to characteristics of adipocytes, including gene expression, and will then entail randomizing subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone). Changes in insulin resistance will be associated with changes in adipocyte morphology and gene expression.

Official title: Integrating the Genetic and Metabolic Faces of Obesity

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

Detailed description: Healthy overweight/obese individuals will be screened for insulin resistance. Both insulin resistant individuals and insulin sensitive individuals (to serve as controls) will be eligible to enroll. Fat cel biopsy and CT scan of the abdomen is required at baseline and after an intervention with either weight loss or pioglitazone (drug to improve insulin resistance). Subjects will repeat insulin resistance test after the intervention as well. Subjects will learn much about their metabolism in this study, and will have an opportunity to improve their insulin resistance.

Minimum eligible age: 30 Years. Maximum eligible age: 65 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- nondiabetic defined as fasting plasma glucose < 126 mg/dL

- body mass index 27 to 35 kg/m2

- no major organ diseases

- able to come to Stanford for regular clinical research center visits

- English speaking or has own translator

Exclusion Criteria:

- pregnancy/lactation

- history of eating disorder or major psychiatric illness

- allergy to thiazolidenedione

- elevation of liver enzymes (> 2. 5 times upper normal limit)

Tracey McLaughlin, MD, MS, Phone: 650-723-7024

Stanford University, Stanford, California 94305, United States; Recruiting
Tracey McLaughlin, MD, MS, Phone: 650-723-7024
Tracey McLaughlin, MD, MS, Sub-Investigator
Gerald Reaven, MD, Principal Investigator

Start date: October 2005
End date: July 2010
Last updated: December 1, 2006