Pericardial Adipose Tissue and Sex HormonesNCT03035526
Sex Hormones and Pericardial Adipose Tissue
An observational study of Pericardial Adipose Tissue and Sex Hormones, run by Gulhane School of Medicine.
Trial summary
In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males. Read more about this study
- Who is it for?
- Ages 45 to 84 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pericardial Adipose Tissue and Sex Hormones
- How many people
- 3,213 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jan 2002
- 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 45 to 84 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3161 men (45-84 years old; white, black, Hispanic, or Chinese) at 6 centers in the United States
Who may be able to join
- 3213 males
- African American
- Caucasian
- Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002)
Who cannot join
- Patients with known coronary artery disease
About this study
Official title: Do Endogenous Sex Hormones Affect Pericardial Adipose Tissue Volume of Males in The Multi-Ethnic Study of Atherosclerosis (MESA)?
In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3161 men (45-84 years old) | 3161 men without known coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation ship between pericardial adipose tissue and sex hormones in males
Total testosterone and sex hormone binding globulin levels were related with pericardial adipose tissue
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2000
- Primary completionJan 2002
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericardial Adipose Tissue and Sex HormonesStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydogan Aydogdu, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035526
- Sponsor's protocol ID
- AA1972
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Endogenous Sex Hormones Affect Pericardial Adipose Tissue Volume of Males in The Multi-Ethnic Study of Atherosclerosis (MESA)?
- ClinicalTrials.gov ID
- NCT03035526
- Acronym / sponsor ID
- AA1972
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,213 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2000 (actual)
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (actual)
- First posted
- 30 Jan 2017 (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.
In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3161 men (45-84 years old) | – | –3161 men without known coronary artery disease |
Who may qualify
- Ages
- 45 to 84 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3161 men (45-84 years old; white, black, Hispanic, or Chinese) at 6 centers in the United States
Key inclusion criteria (4 listed)
- 3213 males
- African American
- Caucasian
- Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002)
Key exclusion criteria (1 listed)
- Patients with known coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relation ship between pericardial adipose tissue and sex hormones in males
Time frame: years
Total testosterone and sex hormone binding globulin levels were related with pericardial adipose tissue
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 30 Jan 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pericardial Adipose Tissue and Sex Hormones, run by Gulhane School of Medicine.
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 4 inclusion and 1 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Relation ship between pericardial adipose tissue and sex hormones in males (time frame: years). 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 30 Jan 2017.