Tongji-Ezhou Study

Recruiting

• Conditions: Nutritional and Metabolic Diseases; Metabolic Syndrome; Risk Factor, Cardiovascular; Diabetes; Cardiovascular Diseases; Obesity; Environmental Exposure
• Interventions: Other: Dietary and environmental exposure (Observational study)

• Registration Number: NCT03845868
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-16
• Primary Completion: 2019-01-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-16
• Last Update Submitted: 2019-02-16
• Study First Posted: 2019-02-19
• Last Update Posted: 2019-02-19
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ezhou CDC physical examination center	Dietary and environmental exposure (Observational study)	-
Egang hospital physical examination center	Dietary and environmental exposure (Observational study)	-

Primary Outcome Measures

Name	Time	Method
Diabetic complications	mean follow up of 10 years	Development of diabetic complications
Incidence of diabetes	5 years	Type 2 diabetes was diagnosed when FPG ≥ 7.0 mmol/L and/or OGTT2h ≥ 11.1 mmol/L, or using diabetic medication (self-report).
Incidence of metabolic syndrome	5 years	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.
Incidence of cardiovascular diseases	mean follow up of 10 years	Cardiovascular death, stroke, myocardial infarction, heart failure

Trial Locations

Locations (1)

Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China