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Completed

NCT Number: NCT03421444

Beijing Children and Adolescents Metabolic Syndrome Study (BCAMS 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.

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Key information

Conditions

Obesity Body Weight Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children or their parents refused to participate in the study

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Metabolic syndrome

    Time frame: Baseline

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

Secondary outcomes

  1. Metabolic syndrome

    Time frame: At 10-year follow-up

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

  2. Obesity

    Time frame: Baseline

    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.

  3. Obesity

    Time frame: At10-year follow-up

    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).

  4. Insulin resistance

    Time frame: Baseline

    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.

  5. Insulin resistance

    Time frame: At 10-year follow-up

    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.

  6. Hypertension

    Time frame: Baseline

    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.

  7. Hypertension

    Time frame: At 10-year follow-up

    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.

  8. Hyperglycemia

    Time frame: Baseline

    The concentrations of plasma glucose (mmol/L).

  9. Hyperglycemia

    Time frame: At 10-year follow-up

    The concentrations of plasma glucose (mmol/L).

  10. Triglyceride (TG)

    Time frame: Baseline

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

  11. Triglyceride (TG)

    Time frame: At 10-year follow-up

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

  12. Total cholesterol (TC)

    Time frame: Baseline

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

  13. Total cholesterol (TC)

    Time frame: At 10-year follow-up

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

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

    Time frame: Baseline

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

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

    Time frame: At 10-year follow-up

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

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

    Time frame: Baseline

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

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

    Time frame: At 10-year follow-up

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

  18. Left ventricular mass

    Time frame: At 10-year follow-up

    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.

  19. Non Alcoholic Fatty Liver Disease

    Time frame: At 10-year follow-up

    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.

  20. Self-concept

    Time frame: At 10-year follow-up

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Capital Institute of Pediatrics, China

Registry information

Acronym: BCAMS

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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