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OpenTrials
Completed

NCT Number: NCT00285844

Integrating the Genetic and Metabolic Faces of Obesity

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.

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Key information

Conditions

Insulin Resistance Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 thiazolidinedione
  • elevation of liver enzymes (> 2.5 times upper normal limit)

Treatment and study plan

Weight Loss

Behavioral

Thiazolidinedione

Drug

Primary outcomes

  1. Adipose Cell Size Distribution

    Time frame: 2005-2012

Secondary outcomes

  1. Adipose Tissue Gene Expression

    Time frame: 2005-2013

Other outcomes

  1. Insulin-Mediated Glucose Uptake

    Time frame: 2005-2012

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2006
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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