Sex Differences in Gene Expression in Human Adipose Tissue | NCT00677651

Studies
Sex Differences in Gene Expression in Human Adipose Tissue

NCT00677651

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Aug 18, 2009Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Healthy
Obesity

Interventions

Adipose Biopsy
Blood sample
CT Scan
DEXA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

May 12, 2008

First Submission Date that Met QC Criteria

May 12, 2008

First Posted Date

May 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2009

Last Update Posted Date

Aug 18, 2009Estimated

Name	Class
University of Maryland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Five caucasian women	Procedure: Adipose Biopsy Procedure: Blood sample Radiation: CT Scan Radiation: DEXA
2		Five caucasian men	Procedure: Adipose Biopsy Procedure: Blood sample Radiation: CT Scan Radiation: DEXA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adipose Biopsy	Procedure	Adipose tissue will be sampled from the abdomen and buttock	1 2

Measure	Description	Time Frame
Adipose and blood sampling		1 year

Measure	Description	Time Frame
CT scan and DEXA scan		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

General Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Chang, M.D.	UCSD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD		La Jolla	California	91963-0063	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided