Metabolic SyndromeNCT01430338
Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans
An observational study of Metabolic Syndrome, run by Korea University at 1 site in South Korea.
Trial summary
Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Dec 2011
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent 18FDG-PET/CT scan year between 2008-2010.
Who may be able to join
- Patients who underwent 18FDG-PET/CT scan year between 2008-2010
Who cannot join
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension
- Severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. So it is important to know the different metabolic characteristics in human adults who have detected BAT. Therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
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 |
|---|---|---|
| BAT | brown adipose tissue detected, undetected |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence metabolic syndrome
Measured: 5 months
Secondary outcomes (4)
BMI
Measured: 5 months
visceral fat area
Measured: 5 months
adipokines
Measured: 5 months
sarcopenia
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. M. Choi, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430338
- Sponsor's protocol ID
- BAT
- Status last verified
- Sep 2011
- First submitted
- 24 Aug 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans
- ClinicalTrials.gov ID
- NCT01430338
- Acronym / sponsor ID
- BAT
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- First posted
- 8 Sep 2011 (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.
Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. So it is important to know the different metabolic characteristics in human adults who have detected BAT. Therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT | – | –brown adipose tissue detected, undetected |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent 18FDG-PET/CT scan year between 2008-2010.
Key inclusion criteria (1 listed)
- Patients who underwent 18FDG-PET/CT scan year between 2008-2010
Key exclusion criteria (4 listed)
- History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
- Diabetes
- Stage 2 hypertension
- Severe renal or hepatic 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
presence metabolic syndrome
Time frame: 5 months
4 secondary outcomes
BMI
Time frame: 5 months
visceral fat area
Time frame: 5 months
adipokines
Time frame: 5 months
sarcopenia
Time frame: 5 months
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 17 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Syndrome, run by Korea University at 1 site in South Korea.
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 1 inclusion and 4 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 17 Mar 2015. 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 South Korea. 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?
presence metabolic syndrome (time frame: 5 months). 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 17 Mar 2015.