Tongji-Ezhou Study

Obesity Clinical Trial

— TJEZ  

Official title:

Tongji-Ezhou Prospectively Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03845868
• Other study ID #: TJEZ2013
• Status: Recruiting
• Start date: April 16, 2013
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2019
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tongji-Ezhou study (TJEZ) is a prospective cohort study launched at 2013 in EZhou city, Hubei province, with the goal of recruiting and assessing 10,000 individuals and then following them for at least 2 decades. In addition, blood samples would be collected every 3-5 years among 6000 of them to investigate the nutritional biomarkers and potential determinants of chronic diseases such as obesity, type 2 diabetes, metabolic syndrome, and cardiovascular disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2019
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• (i) permanent residence in Ezhou district (minimum of 9 months); (ii) written informed consent; (iii) age = 20 years old at the time of enrolling in the study.

Exclusion Criteria:

• (i) with chemotherapy or radiotherapy for cancer and other severe diseases.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Environmental Exposure
• Metabolic Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Nutritional and Metabolic Diseases
• Obesity
• Risk Factor, Cardiovascular

Intervention

Other:
• Dietary and environmental exposure (Observational study)
Not Available

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diabetes	Type 2 diabetes was diagnosed when FPG = 7.0 mmol/L and/or OGTT2h = 11.1 mmol/L, or using diabetic medication (self-report).	5 years
Primary	Incidence of metabolic syndrome	Metabolic syndrome is defined as using the updated National Cholesterol Education Program/Adult Treatment Panel III criteria for Asian Americans. These criteria require three or more of the following components: (1) central obesity (waist circumference of =90 cm for men or =80 cm for women), (2) triglycerides of =1.7 mmol/L, (3) HDL-C of <1.03 mmol/L for men or <1.30 mmol/L for women, (4) blood pressure of =130/85 mmHg or on medication for hypertension, and (5) fasting glucose of =5.6 mmol/L.	5 years
Primary	Diabetic complications	Development of diabetic complications	mean follow up of 10 years
Primary	Incidence of cardiovascular diseases	Cardiovascular death, stroke, myocardial infarction, heart failure	mean follow up of 10 years