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Genetics of Obesity in Chinese Youngs (GOCY)

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ClinicalTrials.gov Identifier: NCT01084967
Recruitment Status : Recruiting
First Posted : March 11, 2010
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date March 10, 2010
First Posted Date March 11, 2010
Last Update Posted Date April 26, 2016
Study Start Date March 2009
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01084967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetics of Obesity in Chinese Youngs
Official Title Study of Clinical Characteristics and Genetic Susceptibility in Chinese Obese Youngs
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood,fasting serum and morning urine
Sampling Method Probability Sample
Study Population 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.
Condition
  • Obesity
  • Metabolic Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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 1500, lean healthy control group 1500
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2016)
3000
Original Estimated Enrollment
 (submitted: March 10, 2010)
2000
Estimated Study Completion Date April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Guang Ning, MD.PhD 86-21-64370045 ext 665340 guangning@medmail.com.cn
Contact: Jie Hong, PhD 86-21-64370045 ext 665345 hongjie13d@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01084967
Other Study ID Numbers CCEMD008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Guang Ning, Shanghai Jiao Tong University School of Medicine
Study Sponsor Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Guang Ning, MD.PhD Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date April 2016