Clinical trial NCT01084967: Genetics of Obesity in Chinese Youngs
Official title: Study of Clinical Characteristics and Genetic Susceptibility in Chinese Obese Youngs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Metabolic Syndrome
Keywords: obesity
metabolic syndrome
genetic risk markers
copy number variation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 8000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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, gut flora and genetic risk factors will be evaluated in the study subjects.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Guang Ning, MD.PhD
role: STUDY_CHAIR
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jie Hong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jiqiu Wang, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong J, Bo T, Xi L, Xu X, He N, Zhan Y, Li W, Liang P, Chen Y, Shi J, Li D, Yan F, Gu W, Wang W, Liu R, Wang J, Wang Z, Ning G. Reversal of Functional Brain Activity Related to Gut Microbiome and Hormones After VSG Surgery in Patients With Obesity. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3619-e3633. doi: 10.1210/clinem/dgab297.