Beijing Children and Adolescents Metabolic Syndrome Study (BCAMS Study) (BCAMS)

January 29, 2018 updated by: Ming Li, Peking Union Medical College Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

19593

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic syndrome
Time Frame: At 10-year follow-up
Metabolic syndrome in adolescents and adults after follow-up was defined by the harmonized definition.
At 10-year follow-up
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.
Baseline
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).
At10-year follow-up
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.
Baseline
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.
At 10-year follow-up
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.
Baseline
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.
At 10-year follow-up
Hyperglycemia
Time Frame: Baseline
The concentrations of plasma glucose (mmol/L).
Baseline
Hyperglycemia
Time Frame: At 10-year follow-up
The concentrations of plasma glucose (mmol/L).
At 10-year follow-up
Triglyceride (TG)
Time Frame: Baseline
The concentrations of plasma triglyceride (TG) (mmol/L).
Baseline
Triglyceride (TG)
Time Frame: At 10-year follow-up
The concentrations of plasma triglyceride (TG) (mmol/L).
At 10-year follow-up
Total cholesterol (TC)
Time Frame: Baseline
The concentrations of plasma total cholesterol (TC) (mmol/L).
Baseline
Total cholesterol (TC)
Time Frame: At 10-year follow-up
The concentrations of plasma total cholesterol (TC) (mmol/L).
At 10-year follow-up
High-density lipoprotein cholesterol(HDL-C)
Time Frame: Baseline
The concentrations of plasma high-density lipoprotein cholesterol(HDL-C) (mmol/L).
Baseline
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).
At 10-year follow-up
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline
The concentrations of plasma triglyceride low-density lipoprotein cholesterol (LDL-C) (mmol/L).
Baseline
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).
At 10-year follow-up
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.
At 10-year follow-up
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.
At 10-year follow-up
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.
At 10-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Chao Yang Hospital
Capital Institute of Pediatrics, China

Investigators

  • Principal Investigator: Ming Li, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2004

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCAMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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