Integrating the Genetic and Metabolic Faces of Obesity - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

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 National Clinical Trials Identifier (NCT ID):

McLaughlin T, Deng A, Gonzales O, Aillaud M, Yee G, Lamendola C, Abbasi F, Connolly AJ, Sherman A, Cushman SW, Reaven G, Tsao PS. Insulin resistance is associated with a modest increase in inflammation in subcutaneous adipose tissue of moderately obese women. Diabetologia. 2008 Dec;51(12):2303-8. Epub 2008 Sep 30.

Study ID Numbers:	RDK071309
Study First Received:	January 31, 2006
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00285844 History of Changes
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:

Obesity
Metabolic Diseases
Disease
Physiological Effects of Drugs
2,4-thiazolidinedione
Overweight
Pharmacologic Actions
Body Weight
Hyperinsulinism

Signs and Symptoms
Hypoglycemic Agents
Pathologic Processes
Syndrome
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009