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ObesityBCAMSNCT03421444

Beijing Children and Adolescents Metabolic Syndrome Study (BCAMS Study)

An observational study of Obesity and Metabolic Disease, run by Peking Union Medical College Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Base on enriched resources from the Metabolic Syndrome cohort in children, a long-term prospective cohort study will be carried out. This cohort is a unique biochemical and genetic database of Chinese population with large number of subjects in the world. Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Metabolic Disease
How many people
19,593 participants
Where
No sites listed yet
Study dates
Apr 2004to Oct 2004
How long will I take part?
10 Years
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: School children, aged 6-18 years, from four of the eight urban districts and three of seven rural districts in the Beijing area

Who may be able to join

  • Children aged 6 to 18 years old from Beijing area in China

Who cannot join

  • Children or their parents refused to participate in the study

About this study

Base on enriched resources from the Metabolic Syndrome cohort in children, a long-term prospective cohort study will be carried out. This cohort is a unique biochemical and genetic database of Chinese population with large number of subjects in the world. By collecting information of disease history and lifestyle, measuring clinical and metabolic parameters, especially biomarkers which can reflect the underlying mechanism of insulin resistance and metabolic syndrome, we intend to sort out some unique biochemical and genetic markers for Chinese population.

Read the detailed description

A representative sample of 19,593 school children, aged 6-18 years, were chosen from four of the eight urban districts and three of seven rural districts in the Beijing area between April and October, 2004. Among these children and adolescents, 4,500 were recognized as having risk factors defined by the presence of any one of the following: overweight, total cholesterol (TC) ≥ 5.2 mmol/L, triglyceride (TG) ≥ 1.7 mmol/L or fasting glucose (FG) ≥ 5.6 mmol/L based on initial finger capillary blood tests. Moreover, all subjects at increased risk for metabolic syndrome, together with a parallel reference population of 1,095 children, were invited to undergo medical examinations for verification based on venipuncture blood samples. Clinical data, biomarkers including adipokines, and lifestyle factors such as physical activity and diet were measured and documented. Genetic variants previously reported from genome-wide association study (GWAS) of obesity and diabetes and DNA-methylation were also assessed. Further, high-throughput analysis of proteomics and metabolomics of the blood samples were conducted. Cross-sectional and follow-up evaluations will be undertaken. The unique biochemical and genetic markers for Chinese population will be identified in the BCAMS study. The biomarkers will build a solid foundation for progressive study on mechanism of metabolic diseases and lead to early prediction of these diseases.

Being tested
No intervention
Keywords
Children, Obesity, Metabolic Disease
Medical subject headings
Obesity, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic syndrome

    The presence of pediatric metabolic syndrome (MS) at baseline was defined by the modified criteria of Adult Treatment Panel III (ATP III).

    Measured: Baseline

Secondary outcomes (20)
  1. Metabolic syndrome

    Metabolic syndrome in adolescents and adults after follow-up was defined by the harmonized definition.

    Measured: At 10-year follow-up

  2. Obesity

    The participants' height and weight were measured under standardized conditions by trained staff. Body mass index (BMI) was calculated as weight (kg) divided by height squared (m^2). Normal weight, overweight and obesity were defined by age- and gender-specific BMI percentiles according to the criteria from the Working Group on Obesity in China.

    Measured: Baseline

  3. Obesity

    The participants' height and weight were measured under standardized conditions by trained staff. Body mass index (BMI) was calculated as weight (kg) divided by height squared (m^2).

    Measured: At10-year follow-up

  4. Insulin resistance

    Insulin resistance index was calculated by homeostasis model assessment of insulin resistance (HOMA-IR), HOMA-IR = fasting insulin (mU/L) × FG (mmol/L) / 22.5.

    Measured: Baseline

  5. Insulin resistance

    Insulin resistance index was calculated by homeostasis model assessment of insulin resistance (HOMA-IR), HOMA-IR = fasting insulin (mU/L) × FG (mmol/L) / 22.5.

    Measured: At 10-year follow-up

  6. Hypertension

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in the right arm three times, 10 minutes apart, and the average of the three measurements was used in the analysis.Hypertension is defined by SBP / DBP ≥ 90th percentile for age, gender for subjects less than 18 years.

    Measured: Baseline

  7. Hypertension

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in the right arm three times, 10 minutes apart, and the average of the three measurements was used in the analysis.Hypertension is defined by SBP ≥ 130 mmHg or DBP ≥ 85 mmHg for adults.

    Measured: At 10-year follow-up

  8. Hyperglycemia

    The concentrations of plasma glucose (mmol/L).

    Measured: Baseline

  9. Hyperglycemia

    The concentrations of plasma glucose (mmol/L).

    Measured: At 10-year follow-up

  10. Triglyceride (TG)

    The concentrations of plasma triglyceride (TG) (mmol/L).

    Measured: Baseline

  11. Triglyceride (TG)

    The concentrations of plasma triglyceride (TG) (mmol/L).

    Measured: At 10-year follow-up

  12. Total cholesterol (TC)

    The concentrations of plasma total cholesterol (TC) (mmol/L).

    Measured: Baseline

  13. Total cholesterol (TC)

    The concentrations of plasma total cholesterol (TC) (mmol/L).

    Measured: At 10-year follow-up

  14. High-density lipoprotein cholesterol(HDL-C)

    The concentrations of plasma high-density lipoprotein cholesterol(HDL-C) (mmol/L).

    Measured: Baseline

  15. High-density lipoprotein cholesterol(HDL-C)

    The concentrations of plasma high-density lipoprotein cholesterol(HDL-C) (mmol/L).

    Measured: At 10-year follow-up

  16. Low-density lipoprotein cholesterol (LDL-C)

    The concentrations of plasma triglyceride low-density lipoprotein cholesterol (LDL-C) (mmol/L).

    Measured: Baseline

  17. Low-density lipoprotein cholesterol (LDL-C)

    The concentrations of plasma triglyceride low-density lipoprotein cholesterol (LDL-C) (mmol/L).

    Measured: At 10-year follow-up

  18. Left ventricular mass

    Assessment by a non-invasive transthoracic echocardiogram using a LOGIQ P5 B-mode ultrasonogram equipped (LOGIQ P5, GE Ultrasound, Korea) with a 2.5-3.5 MHz probe.

    Measured: At 10-year follow-up

  19. Non Alcoholic Fatty Liver Disease

    Nonalcoholic fatty liver disease (NAFLD) was diagnosed by B ultrasonography according to the 2010 Prevention and Treatment Guidelines for NAFLD published by the Society of Hepatology, Chinese Medical Association.

    Measured: At 10-year follow-up

  20. Self-concept

    The Chinese version of the Self-Description Questionnaire II (SDQ-II) was used to assess self-concept.

    Measured: At 10-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study startApr 2004
  3. Primary completionOct 2004
  4. Study completionOct 2004

Resources

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
19,593 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03421444
Sponsor's protocol ID
BCAMS
Acronym
BCAMS
Status last verified
Jan 2018
First submitted
9 Jan 2018
Last updated
5 Feb 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li L, Yin J, Cheng H, Wang Y, Gao S, Li M, Grant SF, Li C, Mi J, Li M. Identification of Genetic and Environmental Factors Predicting Metabolically Healthy Obesity in Children: Data From the BCAMS Study. J Clin Endocrinol Metab. 2016 Apr;101(4):1816-25. doi: 10.1210/jc.2015-3760. Epub 2016 Feb 25.

    PubMed 26913634
  • Wang Q, Yin J, Xu L, Cheng H, Zhao X, Xiang H, Lam HS, Mi J, Li M. Prevalence of metabolic syndrome in a cohort of Chinese schoolchildren: comparison of two definitions and assessment of adipokines as components by factor analysis. BMC Public Health. 2013 Mar 21;13:249. doi: 10.1186/1471-2458-13-249.

    PubMed 23514611
  • Li L, Fu J, Yu XT, Li G, Xu L, Yin J, Cheng H, Hou D, Zhao X, Gao S, Li W, Li C, Grant SFA, Li M, Xiao Y, Mi J, Li M. Sleep Duration and Cardiometabolic Risk Among Chinese School-aged Children: Do Adipokines Play a Mediating Role? Sleep. 2017 May 1;40(5):zsx042. doi: 10.1093/sleep/zsx042.

    PubMed 28329079
  • Feng D, Zhang J, Fu J, Wu H, Wang Y, Li L, Zhao Y, Li M, Gao S. Association between sleep duration and cardiac structure in youths at risk for metabolic syndrome. Sci Rep. 2016 Dec 14;6:39017. doi: 10.1038/srep39017.

    PubMed 27966597
  • Li G, Xu L, Zhao Y, Li L, Fu J, Zhang Q, Li N, Xiao X, Li C, Mi J, Gao S, Li M. Leptin-adiponectin imbalance as a marker of metabolic syndrome among Chinese children and adolescents: The BCAMS study. PLoS One. 2017 Oct 11;12(10):e0186222. doi: 10.1371/journal.pone.0186222. eCollection 2017.

    PubMed 29020116
  • Fu J, Li G, Li L, Yin J, Cheng H, Han L, Zhang Q, Li N, Xiao X, Grant SFA, Li M, Gao S, Mi J, Li M. The role of established East Asian obesity-related loci on pediatric leptin levels highlights a neuronal influence on body weight regulation in Chinese children and adolescents: the BCAMS study. Oncotarget. 2017 Aug 24;8(55):93593-93607. doi: 10.18632/oncotarget.20547. eCollection 2017 Nov 7.

    PubMed 29212175
  • Fu J, Hou C, Li L, Feng D, Li G, Li M, Li C, Gao S, Li M. Vitamin D modifies the associations between circulating betatrophin and cardiometabolic risk factors among youths at risk for metabolic syndrome. Cardiovasc Diabetol. 2016 Oct 6;15(1):142. doi: 10.1186/s12933-016-0461-y.

    PubMed 27716289
  • Li G, Yin J, Fu J, Li L, Grant SFA, Li C, Li M, Mi J, Li M, Gao S. FGF21 deficiency is associated with childhood obesity, insulin resistance and hypoadiponectinaemia: The BCAMS Study. Diabetes Metab. 2017 Jun;43(3):253-260. doi: 10.1016/j.diabet.2016.12.003. Epub 2017 Jan 27.

    PubMed 28139438
  • Yi X, Zhu H, Zhong L, He M, Gao S, Li M. Blood methylation signatures in childhood obesity and risk of cardiac hypertrophy in young adults: Findings from the BCAMS study and Mendelian randomization analysis. J Nutr Biochem. 2025 Oct;144:109979. doi: 10.1016/j.jnutbio.2025.109979. Epub 2025 May 27.

    PubMed 40441498
  • Wang D, Feng D, Wang Y, Dong P, Wang Y, Zhong L, Li B, Fu J, Xiao X, Speakman JR, Li M, Gao S. Angiopoietin-Like Protein 8/Leptin Crosstalk Influences Cardiac Mass in Youths With Cardiometabolic Risk: The BCAMS Study. Front Endocrinol (Lausanne). 2022 Jan 25;12:788549. doi: 10.3389/fendo.2021.788549. eCollection 2021.

    PubMed 35145478
  • Wu Y, Zhong L, Li G, Han L, Fu J, Li Y, Li L, Zhang Q, Guo Y, Xiao X, Qi L, Li M, Gao S, Willi SM. Puberty Status Modifies the Effects of Genetic Variants, Lifestyle Factors and Their Interactions on Adiponectin: The BCAMS Study. Front Endocrinol (Lausanne). 2021 Dec 24;12:737459. doi: 10.3389/fendo.2021.737459. eCollection 2021.

    PubMed 35002951
  • Li Y, Feng D, Esangbedo IC, Zhao Y, Han L, Zhu Y, Fu J, Li G, Wang D, Wang Y, Li M, Gao S, Willi SM. Insulin resistance, beta-cell function, adipokine profiles and cardiometabolic risk factors among Chinese youth with isolated impaired fasting glucose versus impaired glucose tolerance: the BCAMS study. BMJ Open Diabetes Res Care. 2020 Feb;8(1):e000724. doi: 10.1136/bmjdrc-2019-000724.

    PubMed 32049638
  • Fu J, Wang Y, Li G, Han L, Li Y, Li L, Feng D, Wu Y, Xiao X, Li M, Grant SFA, Li M, Gao S. Childhood sleep duration modifies the polygenic risk for obesity in youth through leptin pathway: the Beijing Child and Adolescent Metabolic Syndrome cohort study. Int J Obes (Lond). 2019 Aug;43(8):1556-1567. doi: 10.1038/s41366-019-0405-1. Epub 2019 Jul 8.

    PubMed 31285522
  • Wu Y, Yu X, Li Y, Li G, Cheng H, Xiao X, Mi J, Gao S, Willi SM, Li M. Adipose Tissue Mediates Associations of Birth Weight with Glucose Metabolism Disorders in Children. Obesity (Silver Spring). 2019 May;27(5):746-755. doi: 10.1002/oby.22421. Epub 2019 Feb 27.

    PubMed 30811103
  • Li G, Han L, Wang Y, Zhao Y, Li Y, Fu J, Li M, Gao S, Willi SM. Evaluation of ADA HbA1c criteria in the diagnosis of pre-diabetes and diabetes in a population of Chinese adolescents and young adults at high risk for diabetes: a cross-sectional study. BMJ Open. 2018 Aug 8;8(8):e020665. doi: 10.1136/bmjopen-2017-020665.

    PubMed 30093511

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Metabolic Disease, run by Peking Union Medical College Hospital.

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 5 Feb 2018. 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?

Metabolic syndrome (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03421444, which also lists 15 linked publications.

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 5 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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