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| Sponsored by: |
Stanford University |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00285844 |
Purpose
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.
| Condition | Intervention | Phase |
|
Insulin Resistance Obesity Metabolic Syndrome |
Behavioral: weight loss Drug: thiazolidinedione |
Phase IV |
| MedlinePlus related topics: | Obesity Weight Control |
| ChemIDplus related topics: | Insulin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study |
| Official Title: | Integrating the Genetic and Metabolic Faces of Obesity |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2009 |
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.
Eligibility
| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tracey McLaughlin, MD, MS | 650-723-7024 | |
| Contact: Cindy Lamendola, RN, MSN | 650-723-7024 |
| United States, California | |||||
| Stanford University | Recruiting | ||||
| Stanford, California, United States, 94305 | |||||
| Contact: Tracey McLaughlin, MD, MS 650-723-7024 | |||||
| Sub-Investigator: Tracey McLaughlin, MD, MS | |||||
| Principal Investigator: Gerald Reaven, MD | |||||
| Stanford University |
| Study Director: | Tracey McLaughlin, MD, MS | Stanford University |
More Information
| Study ID Numbers: | RDK071309 |
| First Received: | January 31, 2006 |
| Last Updated: | December 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00285844 |
| Health Authority: | United States: Food and Drug Administration |
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