Integrating the Genetic and Metabolic Faces of Obesity
December 2, 2024 updated by: Tracey McLaughlin, Stanford University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pioglitazone
IR and IS subjects will be randomized to pioglitazone 45 mg daily for 16 wks for comparison with dietary weight loss intervention
|
|
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Experimental: Dietary Weight Loss
IR and IS subjects will be randomized to dietary weight loss for 16 wks for comparison to pioglitazone intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adipose Cell Size Distribution
Time Frame: 2005-2012
|
2005-2012
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adipose Tissue Gene Expression
Time Frame: 2005-2013
|
2005-2013
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Insulin-Mediated Glucose Uptake
Time Frame: 2005-2012
|
2005-2012
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tracey McLaughlin, MD, MS, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2005
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
January 31, 2006
First Posted (Estimated)
February 2, 2006
Study Record Updates
Last Update Posted (Actual)
December 4, 2024
Last Update Submitted That Met QC Criteria
December 2, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDK071309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.