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Integrating the Genetic and Metabolic Faces of Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285844
First Posted: February 2, 2006
Last Update Posted: November 4, 2016
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.
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Integrating the Genetic and Metabolic Faces of Obesity

Resource links provided by NLM:


Further study details as provided by Tracey McLaughlin, Stanford University:

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

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

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

Enrollment: 88
Study Start Date: October 2005
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00285844


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tracey McLaughlin, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00285844     History of Changes
Other Study ID Numbers: RDK071309
First Submitted: January 31, 2006
First Posted: February 2, 2006
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:
obesity
insulin resistance
thiazolidinedione
weight loss
adipose tissue
metabolic syndrome
diabetes prevention
cardiovascular disease prevention

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs