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Clinical Trials/NCT03845868
NCT03845868RecruitingNot Applicable

Tongji-Ezhou Prospectively Cohort Study

Huazhong University of Science and Technology1 site in 1 country10,000 target enrollmentStarted: April 16, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10,000
Locations
1
Primary Endpoint
Diabetic complications

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Diabetic complications

Time Frame: mean follow up of 10 years

Development of diabetic complications

Incidence of diabetes

Time Frame: 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

Time Frame: 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

Time Frame: mean follow up of 10 years

Cardiovascular death, stroke, myocardial infarction, heart failure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Liegang Liu

Vice dean of School of Public Health, Tongji Medical College

Huazhong University of Science and Technology

Study Sites (1)

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