Beijing Children and Adolescents Metabolic Syndrome Study (BCAMS Study)

Obesity Clinical Trial

— BCAMS  

Official title:

Beijing Children and Adolescents Metabolic Syndrome Study (BCAMS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421444
• Other study ID #: BCAMS
• Status: Completed
• Phase: N/A
• First received: January 9, 2018
• Last updated: January 29, 2018
• Start date: April 2004
• Est. completion date: October 2004

Study information

• Verified date: January 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19593
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Metabolic Syndrome X
• Obesity

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Chao Yang Hospital, Capital Institute of Pediatrics, China

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). doi: 10.1093/sleep/zsx042. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome	The presence of pediatric metabolic syndrome (MS) at baseline was defined by the modified criteria of Adult Treatment Panel III (ATP III).	Baseline
Secondary	Metabolic syndrome	Metabolic syndrome in adolescents and adults after follow-up was defined by the harmonized definition.	At 10-year follow-up
Secondary	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.	Baseline
Secondary	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).	At10-year follow-up
Secondary	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.	Baseline
Secondary	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.	At 10-year follow-up
Secondary	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.	Baseline
Secondary	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.	At 10-year follow-up
Secondary	Hyperglycemia	The concentrations of plasma glucose (mmol/L).	Baseline
Secondary	Hyperglycemia	The concentrations of plasma glucose (mmol/L).	At 10-year follow-up
Secondary	Triglyceride (TG)	The concentrations of plasma triglyceride (TG) (mmol/L).	Baseline
Secondary	Triglyceride (TG)	The concentrations of plasma triglyceride (TG) (mmol/L).	At 10-year follow-up
Secondary	Total cholesterol (TC)	The concentrations of plasma total cholesterol (TC) (mmol/L).	Baseline
Secondary	Total cholesterol (TC)	The concentrations of plasma total cholesterol (TC) (mmol/L).	At 10-year follow-up
Secondary	High-density lipoprotein cholesterol(HDL-C)	The concentrations of plasma high-density lipoprotein cholesterol(HDL-C) (mmol/L).	Baseline
Secondary	High-density lipoprotein cholesterol(HDL-C)	The concentrations of plasma high-density lipoprotein cholesterol(HDL-C) (mmol/L).	At 10-year follow-up
Secondary	Low-density lipoprotein cholesterol (LDL-C)	The concentrations of plasma triglyceride low-density lipoprotein cholesterol (LDL-C) (mmol/L).	Baseline
Secondary	Low-density lipoprotein cholesterol (LDL-C)	The concentrations of plasma triglyceride low-density lipoprotein cholesterol (LDL-C) (mmol/L).	At 10-year follow-up
Secondary	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.	At 10-year follow-up
Secondary	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.	At 10-year follow-up
Secondary	Self-concept	The Chinese version of the Self-Description Questionnaire II (SDQ-II) was used to assess self-concept.	At 10-year follow-up