NCT01084967

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
16.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

17.1 years

First QC Date

March 10, 2010

Last Update Submit

April 20, 2021

Conditions

ObesityMetabolic Syndrome

Keywords

obesitymetabolic syndromegenetic risk markerscopy number variation

Study Arms (2)

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

Eligibility Criteria

Age14 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • pregnancy/lactation
  • Cushing syndrome
  • Hypothyroidism
  • obesity caused by pituitary and hypothalamic lesions
  • drug related obesity
  • history of major psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33950216DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood,fasting serum, morning urine and feces

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Guang Ning, MD.PhD

    Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

  • Jie Hong, MD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Jiqiu Wang, MD.PhD

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, MD.PhD

CONTACT

86-21-64370045guangning@medmail.com.cn

Jie Hong, PhD

CONTACT

86-21-64370045hongjie13d@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

March 1, 2009

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

CN(1)