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Integrating the Genetic and Metabolic Faces of Obesity

Integrating the Genetic and Metabolic Faces of Obesity

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00285844
Enrollment
88
Registered
2006-02-02
Start date
2005-10-31
Completion date
2012-10-31
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity, Metabolic Syndrome

Keywords

obesity, insulin resistance, thiazolidinedione, weight loss, adipose tissue, metabolic syndrome, diabetes prevention, cardiovascular disease prevention

Brief 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.

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.

Interventions

BEHAVIORALweight loss

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Adipose Cell Size Distribution2005-2012

Secondary

MeasureTime frame
Adipose Tissue Gene Expression2005-2013

Other

MeasureTime frame
Insulin-Mediated Glucose Uptake2005-2012

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026