ObesityGOCYNCT01084967
Genetics of Obesity in Chinese Youngs
An observational study of Obesity and Metabolic Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- body mass index (BMI)≥ 30kg/m2
- predominantly east China to minimize population stratification
- willing and able to provide informed consent
Who cannot join
- pregnancy/lactation
- Cushing syndrome
- Hypothyroidism
- obesity caused by pituitary and hypothalamic lesions
- drug related obesity
- history of major psychiatric illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Guang Ning, MD.PhD, 86-21-64370045 ext. 665340, guangning@medmail.com.cn
Jie Hong, PhD, 86-21-64370045 ext. 665345, hongjie13d@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- obesity, metabolic syndrome, genetic risk markers, copy number variation
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lean control group | The healthy lean controls consisted of age-, sex- and geography-matched young volunteers, or "golden standard" lean controls from China Cardiometabolic Disease and Cancer Cohort Study (4C Study). Healthy volunteers: 1. BMI:18.5-22.9kg/m2; 2. Age:14-30 years old; 3. To be proved normal by the examinations of liver and kidney function,blood lipids profile,FBG, PBG, fasting insulin and HbA1c. Controls from 4C Study: 1. 17.0≤BMI≤23.0kg/m2 and waist circumference <85cm for males and <80cm for females; 2. 1.8≤LDL-c≤3.4mmol/l; 3. FBG<6.1, PBG<7.8; 4. HOMA-IR<2.5; 5. BP <140/90mmHg; 6. eGFR>60mL/(min·1.73 m2), ALT<40IU/L, AST<40IU/L; 7. Excluding the history of hyperthyroidism, digestive system diseases, malignant tumors, infectious diseases (hepatitis B) and other systemic wasting diseases; Severe dysfunction of heart, lung and kidney; 8. Not using antihypertensive, hypoglycemic and lipid-lowering drugs； 9. No history of smoking. | |
| obesity group | 1. BMI ≥30kg/m2; 2. Age:14-30 years old; obesity group 4000, lean healthy control group 4000 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD.PhD, Study chair, Shanghai Jiao Tong University School of MedicineJie Hong, MD, Principal investigator, Shanghai Jiao Tong University School of MedicineJiqiu Wang, MD.PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084967
- Sponsor's protocol ID
- CCEMD008
- Acronym
- GOCY
- Status last verified
- May 2026
- First submitted
- 10 Mar 2010
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33950216
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Characteristics and Genetic Susceptibility in Chinese Obese Youngs
- ClinicalTrials.gov ID
- NCT01084967
- Acronym / sponsor ID
- GOCY / CCEMD008
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- obesity, metabolic syndrome, genetic risk markers, copy number variation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy lean control group | – | –The healthy lean controls consisted of age-, sex- and geography-matched young volunteers, or "golden standard" lean controls from China Cardiometabolic Disease and Cancer Cohort Study (4C Study). Healthy volunteers: 1. BMI:18.5-22.9kg/m2; 2. Age:14-30 years old; 3. To be proved normal by the examinations of liver and kidney function,blood lipids profile,FBG, PBG, fasting insulin and HbA1c. Controls from 4C Study: 1. 17.0≤BMI≤23.0kg/m2 and waist circumference <85cm for males and <80cm for females; 2. 1.8≤LDL-c≤3.4mmol/l; 3. FBG<6.1, PBG<7.8; 4. HOMA-IR<2.5; 5. BP <140/90mmHg; 6. eGFR>60mL/(min·1.73 m2), ALT<40IU/L, AST<40IU/L; 7. Excluding the history of hyperthyroidism, digestive system diseases, malignant tumors, infectious diseases (hepatitis B) and other systemic wasting diseases; Severe dysfunction of heart, lung and kidney; 8. Not using antihypertensive, hypoglycemic and lipid-lowering drugs； 9. No history of smoking. |
| obesity group | – | –1. BMI ≥30kg/m2; 2. Age:14-30 years old; obesity group 4000, lean healthy control group 4000 |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- body mass index (BMI)≥ 30kg/m2
- predominantly east China to minimize population stratification
- willing and able to provide informed consent
Key exclusion criteria (6 listed)
- pregnancy/lactation
- Cushing syndrome
- Hypothyroidism
- obesity caused by pituitary and hypothalamic lesions
- drug related obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 33950216Hong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guang Ning, MD.PhD study chair
Shanghai Jiao Tong University School of Medicine
Jie Hong, MD principal investigator
Shanghai Jiao Tong University School of Medicine
Jiqiu Wang, MD.PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guang Ning, MD.PhD (86-21-64370045 ext. 665340, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01084967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.