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Integrating the Genetic and Metabolic Faces of Obesity

NCT ID: NCT00285844

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Insulin Resistance Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pioglitazone

IR and IS subjects will be randomized to pioglitazone 45 mg daily for 16 wks for comparison with dietary weight loss intervention

Group Type EXPERIMENTAL

thiazolidinedione

Intervention Type DRUG

Dietary Weight Loss

IR and IS subjects will be randomized to dietary weight loss for 16 wks for comparison to pioglitazone intervention

Group Type EXPERIMENTAL

weight loss

Intervention Type BEHAVIORAL

Interventions

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weight loss

Intervention Type BEHAVIORAL

thiazolidinedione

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracey McLaughlin, MD, MS

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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McLaughlin T, Liu LF, Lamendola C, Shen L, Morton J, Rivas H, Winer D, Tolentino L, Choi O, Zhang H, Hui Yen Chng M, Engleman E. T-cell profile in adipose tissue is associated with insulin resistance and systemic inflammation in humans. Arterioscler Thromb Vasc Biol. 2014 Dec;34(12):2637-43. doi: 10.1161/ATVBAHA.114.304636. Epub 2014 Oct 23.

Reference Type DERIVED
PMID: 25341798 (View on PubMed)

McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24.

Reference Type DERIVED
PMID: 21865361 (View on PubMed)

McLaughlin T, Deng A, Yee G, Lamendola C, Reaven G, Tsao PS, Cushman SW, Sherman A. Inflammation in subcutaneous adipose tissue: relationship to adipose cell size. Diabetologia. 2010 Feb;53(2):369-77. doi: 10.1007/s00125-009-1496-3. Epub 2009 Oct 9.

Reference Type DERIVED
PMID: 19816674 (View on PubMed)

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. doi: 10.1007/s00125-008-1148-z. Epub 2008 Sep 30.

Reference Type DERIVED
PMID: 18825363 (View on PubMed)

Other Identifiers

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RDK071309

Identifier Type: -

Identifier Source: org_study_id