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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Chao Yang Hospital
Capital Institute of Pediatrics, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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