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Integrating the Genetic and Metabolic Faces of Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00285844
First received: January 31, 2006
Last updated: December 1, 2006
Last verified: December 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrating the Genetic and Metabolic Faces of Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Estimated Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: December 2009
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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285844

Contacts
Contact: Tracey McLaughlin, MD, MS 650-723-7024
Contact: Cindy Lamendola, RN, MSN 650-723-7024

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

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00285844     History of Changes
Other Study ID Numbers: RDK071309
Study First Received: January 31, 2006
Last Updated: December 1, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
obesity
insulin resistance
thiazolidinedione
weight loss
 adipose tissue
metabolic syndrome
diabetes prevention
cardiovascular disease prevention

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

ClinicalTrials.gov processed this record on May 23, 2013