- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845868
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
Status
Recruiting
Conditions
Intervention / Treatment
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:
- Liegang Liu, PhD
- Phone Number: +86-27-83650522
- Email: liegangliu@gmail.com
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJEZ2013
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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