HealthyNCT00677651
Sex Differences in Gene Expression in Human Adipose Tissue
An observational study of Healthy and Obesity, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Adipose Biopsy, Blood sample and CT Scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General Population
Who may be able to join
- Caucasian men and women 20-35 years of age
- Lean (BMI less than 25)
- Obese (BMI 30-35)
Who cannot join
- Hormonal birth control
- Pregnancy
- Smokers
- History of diabetes, kidney, liver or thyroid disease
- History of cancer
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Adipose Biopsy, Blood sample, CT Scan, DEXA
- Keywords
- adipose, lean, obese, overweight, healthy
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose BiopsyProcedure or surgery
Adipose tissue will be sampled from the abdomen and buttock
Blood sampleProcedure or surgery
Blood will be sampled from an IV line
CT ScanRadiation
Single image at the level of the liver
DEXARadiation
Whole body scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Five caucasian women Receives: Procedure: Adipose Biopsy; Procedure: Blood sample; Radiation: CT Scan; Radiation: DEXA | |
| 2 | Five caucasian men Receives: Procedure: Adipose Biopsy; Procedure: Blood sample; Radiation: CT Scan; Radiation: DEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose and blood sampling
Measured: 1 year
Secondary outcomes (1)
CT scan and DEXA scan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Investigators
- Jeffrey Chang, M.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677651
- Sponsor's protocol ID
- 070668
- Status last verified
- Aug 2009
- First submitted
- 12 May 2008
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Gene Expression in Human Adipose Tissue
- ClinicalTrials.gov ID
- NCT00677651
- Acronym / sponsor ID
- 070668
- Keywords
- adipose, lean, obese, overweight, healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Adipose Biopsy, Procedure: Blood sample, Radiation: CT Scan, Radiation: DEXAFive caucasian women |
| 2 | – | Procedure: Adipose Biopsy, Procedure: Blood sample, Radiation: CT Scan, Radiation: DEXAFive caucasian men |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General Population
Key inclusion criteria (3 listed)
- Caucasian men and women 20-35 years of age
- Lean (BMI less than 25)
- Obese (BMI 30-35)
Key exclusion criteria (5 listed)
- Hormonal birth control
- Pregnancy
- Smokers
- History of diabetes, kidney, liver or thyroid disease
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose BiopsyAdipose tissue will be sampled from the abdomen and buttock | Procedure or surgery | 1, 2 |
| Blood sampleBlood will be sampled from an IV line | Procedure or surgery | 1, 2 |
| CT ScanSingle image at the level of the liver | Radiation | 1, 2 |
| DEXAWhole body scan | Radiation | 1, 2 |
Primary outcome
Adipose and blood sampling
Time frame: 1 year
1 secondary outcome
CT scan and DEXA scan
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Chang, M.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipose and blood sampling (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.