NCT06554262

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,938

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

August 10, 2024

Last Update Submit

August 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (1)

Cardiometabolic risk group

Other: No intervention

Interventions

No intervention was involved in this study

Cardiometabolic risk group

Eligibility Criteria

Age6 Years - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • Healthy children and adolescents aged 6-18 years

You may not qualify if:

  • Heart disease Kidney disease Thyroid disease Individuals who take hormone medication Missing data for anthropometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 15, 2024

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

September 1, 2019

Last Updated

August 15, 2024

Record last verified: 2024-08