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Sex Differences in Gene Expression in Human Adipose Tissue

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ClinicalTrials.gov Identifier: NCT00677651
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : August 18, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment
Healthy Obesity Procedure: Adipose Biopsy Procedure: Blood sample Radiation: CT Scan Radiation: DEXA

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sex Differences in Gene Expression in Human Adipose Tissue
Study Start Date : April 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Five caucasian women
Procedure: Adipose Biopsy
Adipose tissue will be sampled from the abdomen and buttock
Procedure: Blood sample
Blood will be sampled from an IV line
Radiation: CT Scan
Single image at the level of the liver
Radiation: DEXA
Whole body scan
2
Five caucasian men
Procedure: Adipose Biopsy
Adipose tissue will be sampled from the abdomen and buttock
Procedure: Blood sample
Blood will be sampled from an IV line
Radiation: CT Scan
Single image at the level of the liver
Radiation: DEXA
Whole body scan


Outcome Measures

Primary Outcome Measures :
  1. Adipose and blood sampling [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. CT scan and DEXA scan [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood, Fat tissue from abdomen and buttock

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
General Population
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677651


Locations
United States, California
UCSD
La Jolla, California, United States, 91963-0063
Sponsors and Collaborators
University of California, San Diego
University of Maryland
Investigators
Principal Investigator: Jeffrey Chang, M.D. UCSD
More Information

Responsible Party: R. Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00677651     History of Changes
Other Study ID Numbers: 070668
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by University of California, San Diego:
adipose
lean
obese
overweight
healthy