Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sex Differences in Gene Expression in Human Adipose Tissue

This study has been completed.
Sponsor:
Collaborator:
University of Maryland
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00677651
First received: May 12, 2008
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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 Intervention
Healthy
Obesity
Procedure: Adipose Biopsy
Procedure: Blood sample
Radiation: CT Scan
Radiation: DEXA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sex Differences in Gene Expression in Human Adipose Tissue

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Adipose and blood sampling [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CT scan and DEXA scan [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, Fat tissue from abdomen and buttock


Estimated Enrollment: 10
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: R. Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00677651     History of Changes
Other Study ID Numbers: 070668
Study First Received: May 12, 2008
Last Updated: August 17, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014