Tongji-Ezhou Study (TJEZ)

February 16, 2019 updated by: Liegang Liu, Huazhong University of Science and Technology

Tongji-Ezhou Prospectively Cohort Study

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 Overview

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Cheng Luo, PhD
        • Principal Investigator:
          • Liangkai Chen, PhD
        • Principal Investigator:
          • Zhou Li, PhD
        • Principal Investigator:
          • Jiawei Yin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples were collected at two medical centrals (retired employees at Egang hospital and working employees at Ezhou CDC). The Retirement Office of Egang hospital and Health checkup center of CDC provided a list of the individuals and invited them to participant in our study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Egang hospital physical examination center
Ezhou CDC physical examination center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 years
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.
5 years
Diabetic complications
Time Frame: mean follow up of 10 years
Development of diabetic complications
mean follow up of 10 years
Incidence of cardiovascular diseases
Time Frame: mean follow up of 10 years
Cardiovascular death, stroke, myocardial infarction, heart failure
mean follow up of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2013

Primary Completion (Actual)

January 31, 2019

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 16, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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