Integrating the Genetic and Metabolic Faces of Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tracey McLaughlin, Stanford University
ClinicalTrials.gov Identifier:
NCT00285844
First received: January 31, 2006
Last updated: December 2, 2013
Last verified: December 2013
  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: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Integrating the Genetic and Metabolic Faces of Obesity

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Adipose Cell Size Distribution [ Time Frame: 2005-2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adipose Tissue Gene Expression [ Time Frame: 2005-2013 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Insulin-Mediated Glucose Uptake [ Time Frame: 2005-2012 ] [ Designated as safety issue: No ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Stanford University

Additional 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
Study First Received: January 31, 2006
Last Updated: December 2, 2013
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
Pioglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014