Integrating the Genetic and Metabolic Faces of Obesity

Obesity Clinical Trial

Official title:

Integrating the Genetic and Metabolic Faces of Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285844
• Other study ID #: RDK071309
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2006
• Last updated: November 3, 2016
• Start date: October 2005
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• weight loss

Drug:
• thiazolidinedione

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin-Mediated Glucose Uptake		2005-2012	No
Primary	Adipose Cell Size Distribution		2005-2012	No
Secondary	Adipose Tissue Gene Expression		2005-2013	No