NCT01336777

Brief Summary

The biological basis for insulin resistance associated with obesity is unknown. By studying equally-overweight/obese individuals who are either insulin resistant or insulin sensitive, the investigators will compare characteristics of fat tissue to test several hypotheses: 1) impaired differentiation and fat storage in the subcutaneous fat depot characterize insulin resistant individuals, who have, as a result, fat in other tissues like liver and muscle, as well as more fat circulating in the blood; 2) inflammation is greater in visceral and/or subcutaneous adipose tissue depots in insulin resistant individuals as compared with insulin sensitive individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

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

August 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

3.8 years

First QC Date

March 30, 2011

Last Update Submit

December 2, 2024

Conditions

Keywords

obesityadipocyte differentiationinflammationinsulin resistancevisceral fatregional fat depots

Outcome Measures

Primary Outcomes (1)

  • Adipose Cell Size

    Harvest adipose tissue from human biopsy. Prepare for cell size analysis using Beckman Multisizer Coulter Counter

    3 years

Secondary Outcomes (2)

  • Macrophage density

    3 years

  • Gene Expression

    3 years

Study Arms (2)

Insulin resistant group

there is no intervention

Insulin sensitive group

There is no intervention

Eligibility Criteria

Age39 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy, nondiabetic volunteers will be recruited from Stanford's General Surgery Preoperative Clinic, Stanford's Bariatric Surgery Clinic, and nonsurgical volunteers who respond to local newspaper advertisements.

You may qualify if:

  • No major organ disease
  • Fasting blood glucose \< 126 mg/dL
  • BMI 25-35 kg/m2
  • Nonpregnant/nonlactating

You may not qualify if:

  • pregnancy/lactation
  • major organ disease
  • drugs that influence insulin resistance
  • unstable body weight or active weight loss program
  • outside BMI range or age range
  • diabetic by fasting glucose criteria 126 mg/dL or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

adipose tissue samples will be frozen for gene expression analysis.

MeSH Terms

Conditions

ObesityInsulin ResistanceDiabetes Mellitus, Type 2Inflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System DiseasesPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 18, 2011

Study Start

August 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations