Cardiometabolic RiskNCT06554262
Visceral Fat and Cardiometabolic Risk
An observational study of Cardiometabolic Risk and Visceral Fat, run by Capital Medical University.
Trial summary
The present study showed that the 75th percentile of visceral fat area in boys and girls is the optimal cutoff for screening cardiometabolic risk and its clustering, but the 80th percentile is the optimal cutoff for hyperglycemia screening in girls. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk, Visceral Fat, Cohort Study
- How many people
- 18,938 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2019
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A total of 8133 participants (mean age =11.8 years, SD =3.3 years) from the China Child and Adolescent Cardiovascular Health completed the visceral fat area assessment by dual-energy X-ray absorptiometry, and 10805 participants from the school-based cardiovascular and bone health program (mean age =11.0 years, SD =3.3 years).
Who may be able to join
- Healthy children and adolescents aged 6-18 years
Who cannot join
- Heart disease Kidney disease Thyroid disease Individuals who take hormone medication Missing data for anthropometry
About this study
Official title: Optimal Visceral Fat Area Cutoffs for Screening Cardiometabolic Risk: a Large-scale Population-based Cohort Study
The present study showed that the 75th percentile of visceral fat area in boys and girls is the optimal cutoff for screening cardiometabolic risk and its clustering, but the 80th percentile is the optimal cutoff for hyperglycemia screening in girls. The investigators proposed simplified cutoffs of 37.19 cm2 and 31.09 cm2 aged 6 to 8 years, 56.76 cm2 and 39.51 cm2 aged 9 to 11 years, 57.03 cm2 and 38.33 cm2 aged 12 to 15 years, and 58.32 cm2 and 53.91 cm2 aged 16 to 18 years for boys and girls, respectively. Both the optimal and simplified methods were verified in a 2-year longitudinal cohort. An improved understanding of the importance of visceral fat to cardiometabolic risk and its clustering in children may yield insight into the risks associated with child obesity and the initial phases of cardiovascular disease development, especially in normal-weight boys.
- Conditions
- Cardiometabolic Risk, Visceral Fat, Cohort Study
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention was involved in this study
| Study group | Role | What they receive |
|---|---|---|
| Cardiometabolic risk group | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral fat area cutoffs and cardiometabolic risk
Based on dual-energy X-ray measurements of visceral fat area, age- and sex-specific visceral fat area cutoffs for screening cardiometabolic risk was developed and validated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study startJan 2013
- Primary completionNov 2015
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 18,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Wang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554262
- Sponsor's protocol ID
- 2012062
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Visceral Fat Area Cutoffs for Screening Cardiometabolic Risk: a Large-scale Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT06554262
- Acronym / sponsor ID
- 2012062
- Conditions
- Cardiometabolic Risk, Visceral Fat, Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,938 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 15 Aug 2024 (actual)
- 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.
The present study showed that the 75th percentile of visceral fat area in boys and girls is the optimal cutoff for screening cardiometabolic risk and its clustering, but the 80th percentile is the optimal cutoff for hyperglycemia screening in girls. The investigators proposed simplified cutoffs of 37.19 cm2 and 31.09 cm2 aged 6 to 8 years, 56.76 cm2 and 39.51 cm2 aged 9 to 11 years, 57.03 cm2 and 38.33 cm2 aged 12 to 15 years, and 58.32 cm2 and 53.91 cm2 aged 16 to 18 years for boys and girls, respectively. Both the optimal and simplified methods were verified in a 2-year longitudinal cohort. An improved understanding of the importance of visceral fat to cardiometabolic risk and its clustering in children may yield insight into the risks associated with child obesity and the initial phases of cardiovascular disease development, especially in normal-weight boys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiometabolic risk group | – | Other: No intervention |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A total of 8133 participants (mean age =11.8 years, SD =3.3 years) from the China Child and Adolescent Cardiovascular Health completed the visceral fat area assessment by dual-energy X-ray absorptiometry, and 10805 participants from the school-based cardiovascular and bone health program (mean age =11.0 years, SD =3.3 years).
Key inclusion criteria (1 listed)
- Healthy children and adolescents aged 6-18 years
Key exclusion criteria (1 listed)
- Heart disease Kidney disease Thyroid disease Individuals who take hormone medication Missing data for anthropometry
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 |
|---|---|---|
| No interventionNo intervention was involved in this study | Other | Cardiometabolic risk group |
Primary outcome
Visceral fat area cutoffs and cardiometabolic risk
Time frame: 2 years
Based on dual-energy X-ray measurements of visceral fat area, age- and sex-specific visceral fat area cutoffs for screening cardiometabolic risk was developed and validated.
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 15 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Risk and Visceral Fat, run by Capital Medical University.
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 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 15 Aug 2024. 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?
Visceral fat area cutoffs and cardiometabolic risk (time frame: 2 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 15 Aug 2024.