NCT00285844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

7 years

First QC Date

January 31, 2006

Last Update Submit

December 2, 2024

Conditions

Insulin ResistanceObesityMetabolic Syndrome

Keywords

obesityinsulin resistancethiazolidinedioneweight lossadipose tissuemetabolic syndromediabetes preventioncardiovascular disease prevention

Outcome Measures

Primary Outcomes (1)

  • Adipose Cell Size Distribution

    2005-2012

Secondary Outcomes (1)

  • Adipose Tissue Gene Expression

    2005-2013

Other Outcomes (1)

  • Insulin-Mediated Glucose Uptake

    2005-2012

Study Arms (2)

pioglitazone

EXPERIMENTAL

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

Drug: thiazolidinedione

Dietary Weight Loss

EXPERIMENTAL

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

Behavioral: weight loss

Interventions

weight lossBEHAVIORAL
Dietary Weight Loss
thiazolidinedioneDRUG
pioglitazone

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy/lactation
  • history of eating disorder or major psychiatric illness
  • allergy to thiazolidinedione
  • elevation of liver enzymes (\> 2.5 times upper normal limit)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (4)

  • 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.

    PMID: 25341798DERIVED

  • 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.

    PMID: 21865361DERIVED

  • 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.

    PMID: 19816674DERIVED

  • 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.

    PMID: 18825363DERIVED

MeSH Terms

Conditions

Insulin ResistanceObesityMetabolic SyndromeWeight Loss

Interventions

2,4-thiazolidinedione

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Tracey McLaughlin, MD, MS

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 2, 2006

Study Start

October 1, 2005

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)