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Integrating the Genetic and Metabolic Faces of Obesity

This study is currently recruiting participants.
Verified by Stanford University, December 2006

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   

U.S. FDA Resources

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

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


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

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

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Facies
Diabetes Mellitus
2,4-thiazolidinedione
Overweight
Insulin
Body Weight
Hyperinsulinism
Signs and Symptoms
Weight Loss
Nutrition Disorders
Overnutrition
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Hypoglycemic Agents
Pathologic Processes
Disease
Syndrome
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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