TJEZ: Tongji-Ezhou Study

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03845868
Collaborator
(none)
10,000
1
152.5
65.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary and environmental exposure (Observational study)

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tongji-Ezhou Prospectively Cohort Study
Actual Study Start Date :
Apr 16, 2013
Actual Primary Completion Date :
Jan 31, 2019
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Egang hospital physical examination center

Other: Dietary and environmental exposure (Observational study)

Ezhou CDC physical examination center

Other: Dietary and environmental exposure (Observational study)

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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.

  3. Diabetic complications [mean follow up of 10 years]

    Development of diabetic complications

  4. Incidence of cardiovascular diseases [mean follow up of 10 years]

    Cardiovascular death, stroke, myocardial infarction, heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huazhong University of Science and Technology Wuhan Hubei China 430030

Sponsors and Collaborators

  • Huazhong University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liegang Liu, Vice dean of School of Public Health, Tongji Medical College, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT03845868
Other Study ID Numbers:
  • TJEZ2013
First Posted:
Feb 19, 2019
Last Update Posted:
Feb 19, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2019