NCT00677651

Brief Summary

This project was created to assess sex differences in adipose tissue gene expression in different locations in the body. The primary objectives are to understand:

  1. 1.The mechanisms of differential body fat distribution in men and women
  2. 2.How body fat distribution is affected by reproductive hormones
  3. 3.The mechanisms linking fat distribution to health risks such as diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

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

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

May 12, 2008

Last Update Submit

August 17, 2009

Conditions

HealthyObesity

Keywords

adiposeleanobeseoverweighthealthy

Outcome Measures

Primary Outcomes (1)

  • Adipose and blood sampling

    1 year

Secondary Outcomes (1)

  • CT scan and DEXA scan

    1 year

Study Arms (2)

1

Five caucasian women

Procedure: Adipose BiopsyProcedure: Blood sampleRadiation: CT ScanRadiation: DEXA

2

Five caucasian men

Procedure: Adipose BiopsyProcedure: Blood sampleRadiation: CT ScanRadiation: DEXA

Interventions

Adipose BiopsyPROCEDURE

Adipose tissue will be sampled from the abdomen and buttock

12
Blood samplePROCEDURE

Blood will be sampled from an IV line

12
CT ScanRADIATION

Single image at the level of the liver

12
DEXARADIATION

Whole body scan

12

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

General Population

You may qualify if:

  • Caucasian men and women 20-35 years of age
  • Lean (BMI less than 25)
  • Obese (BMI 30-35)

You may not qualify if:

  • Hormonal birth control
  • Pregnancy
  • Smokers
  • History of diabetes, kidney, liver or thyroid disease
  • History of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

La Jolla, California, 91963-0063, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Fat tissue from abdomen and buttock

MeSH Terms

Conditions

ObesityOverweight

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jeffrey Chang, M.D.

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations

US(1)