Integrating the Genetic and Metabolic Faces of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285844
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Insulin Resistance Obesity Metabolic Syndrome Behavioral: weight loss Drug: thiazolidinedione Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Integrating the Genetic and Metabolic Faces of Obesity
Study Start Date : October 2005
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Arm Intervention/treatment
Experimental: pioglitazone
IR and IS subjects will be randomized to pioglitazone 45 mg daily for 16 wks for comparison with dietary weight loss intervention
Drug: thiazolidinedione
Experimental: Dietary Weight Loss
IR and IS subjects will be randomized to dietary weight loss for 16 wks for comparison to pioglitazone intervention
Behavioral: weight loss

Primary Outcome Measures :
  1. Adipose Cell Size Distribution [ Time Frame: 2005-2012 ]

Secondary Outcome Measures :
  1. Adipose Tissue Gene Expression [ Time Frame: 2005-2013 ]

Other Outcome Measures:
  1. Insulin-Mediated Glucose Uptake [ Time Frame: 2005-2012 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285844

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Study Director: Tracey McLaughlin, MD, MS Stanford University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tracey McLaughlin, Associate Professor of Medicine, Stanford University Identifier: NCT00285844     History of Changes
Other Study ID Numbers: RDK071309
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tracey McLaughlin, Stanford University:
insulin resistance
weight loss
adipose tissue
metabolic syndrome
diabetes prevention
cardiovascular disease prevention

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs