Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Genetics of Obesity in Chinese Youngs (GOCY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine Identifier:
First received: March 10, 2010
Last updated: July 21, 2013
Last verified: July 2013

March 10, 2010
July 21, 2013
March 2009
September 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01084967 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Genetics of Obesity in Chinese Youngs
Study of Clinical Characteristics and Genetic Susceptibility in Chinese Obese Youngs

The purpose of this study is to explore the pathogenesis and genetic susceptibility of obese subjects,providing a convincing argument for further treatment of obesity and metabolic syndrome.

Obesity has become a major worldwide challenge to public health, owing to an interaction between the obesogenic environment and a strong genetic contribution.Previous studies found that genetic factors determine 40%-70% of obese phenotype.Under such circumstances, the screening of obesity susceptibility gene is particularly important for society or family to take measures to prevent obesity.

Recent extensive genome-wide association studies(GWASs) have identified numerous single nucleotide polymorphisms associated with obesity,but these loci together account for only a small fraction of the known heritable component.Two studies in 2010 Nature,for the first time, put rare copy number variation (CNV)in association with severe early-onset obesity.Their significance lie not only in the discovery of the pathogenic genes of severe early-onset obesity but,more importantly,in providing new strategies for finding out genes that cause complex diseases.

Obese patients and healthy lean controls proved by a series of blood biochemical examinations will be enrolled in this study.The present study intends to use the techniques such as enzyme-linked immunosorbent assay, real-time fluorescence quantitative PCR,gene chip,construction of viral vectors,transfection,taking advantage of the established database,by means of serum assays and functional tests, associate copy number variation with obesity phenotype to explain the root cause of obesity.Meanwhile biomarkers and genetic risk factors will be evaluated in the study subjects.

Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA

Whole blood,fasting serum and morning urine

Probability Sample

The population from which cohorts will be selected include students, residents, staff, and/or faculty who are present on Shanghai Jiaotong University school of medicine, and surrounding areas.

  • Obesity
  • Metabolic Syndrome
Not Provided
  • Healthy lean control group
    BMI:18.5-22.9kg/m2. Age:14-30 years old. To be proved normal by the examinations of liver and kidney function,blood lipids profile,fasting and postprandial plasma glucose, fasting insulin and HbA1c.
  • obesity group with BMI ≥30
    obesity group 1000, lean healthy control group 1000
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • body mass index (BMI)≥ 30kg/m2
  • predominantly east China to minimize population stratification
  • willing and able to provide informed consent

Exclusion Criteria:

  • pregnancy/lactation
  • Cushing syndrome
  • Hypothyroidism
  • obesity caused by pituitary and hypothalamic lesions
  • drug related obesity
  • history of major psychiatric illness
14 Years to 30 Years
Contact: Guang Ning, MD.PhD 86-21-64370045 ext 665340
Contact: Jie Hong, PhD 86-21-64370045 ext 665345
Guang Ning, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Guang Ning, MD.PhD Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP