DiabetesTJEZNCT03845868
Tongji-Ezhou Study
An observational study of Diabetes and Cardiovascular Diseases, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes, Cardiovascular Diseases, Obesity
- What is being tested?
- Dietary and environmental exposure (Observational study)
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2013to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (i) with chemotherapy or radiotherapy for cancer and other severe diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Liegang Liu, PhD, +86-27-83650522, liegangliu@gmail.com
Cheng Luo, PhD
About this study
Official title: 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.
- Conditions
- Diabetes, Cardiovascular Diseases, Obesity, Metabolic Syndrome, Nutritional and Metabolic Diseases, Environmental Exposure
- Being tested
- Dietary and environmental exposure (Observational study)
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Obesity, Metabolic Syndrome, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and environmental exposure (Observational study)Other
| Study group | Role | What they receive |
|---|---|---|
| Egang hospital physical examination center | Not described Receives: Other: Dietary and environmental exposure (Observational study) | |
| Ezhou CDC physical examination center | Not described Receives: Other: Dietary and environmental exposure (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diabetes
Type 2 diabetes was diagnosed when FPG ≥ 7.0 mmol/L and/or OGTT2h ≥ 11.1 mmol/L, or using diabetic medication (self-report).
Measured: 5 years
Incidence of metabolic syndrome
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.
Measured: 5 years
Diabetic complications
Development of diabetic complications
Measured: mean follow up of 10 years
Incidence of cardiovascular diseases
Cardiovascular death, stroke, myocardial infarction, heart failure
Measured: mean follow up of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start16 Apr 2013
- Primary completion31 Jan 2019
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845868
- Sponsor's protocol ID
- TJEZ2013
- Acronym
- TJEZ
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun T, Deng Y, Geng X, Fang Q, Li X, Chen L, Zhan M, Li D, Zhu K, Li H, Liu L. Plasma Alkylresorcinol Metabolite, a Biomarker for Whole-Grain Intake, Is Inversely Associated with Risk of Nonalcoholic Fatty Liver Disease in a Case-Control Study of Chinese Adults. J Nutr. 2022 Apr 1;152(4):1052-1058. doi: 10.1093/jn/nxab404.
PubMed 35091747
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongji-Ezhou Prospectively Cohort Study
- ClinicalTrials.gov ID
- NCT03845868
- Acronym / sponsor ID
- TJEZ / TJEZ2013
- Conditions
- Diabetes, Cardiovascular Diseases, Obesity, Metabolic Syndrome, Nutritional and Metabolic Diseases, Environmental Exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 16 Apr 2013 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egang hospital physical examination center | – | Other: Dietary and environmental exposure (Observational study) |
| Ezhou CDC physical examination center | – | Other: Dietary and environmental exposure (Observational study) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (i) with chemotherapy or radiotherapy for cancer and other severe diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary and environmental exposure (Observational study) | Other | Egang hospital physical examination center, Ezhou CDC physical examination center |
Primary outcome
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.
Diabetic complications
Time frame: mean follow up of 10 years
Development of diabetic complications
Incidence of cardiovascular diseases
Time frame: mean follow up of 10 years
Cardiovascular death, stroke, myocardial infarction, heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 35091747Sun T, Deng Y, Geng X, Fang Q, Li X, Chen L, Zhan M, Li D, Zhu K, Li H, Liu L. Plasma Alkylresorcinol Metabolite, a Biomarker for Whole-Grain Intake, Is Inversely Associated with Risk of Nonalcoholic Fatty Liver Disease in a Case-Control Study of Chinese Adults. J Nutr. 2022 Apr 1;152(4):1052-1058. doi: 10.1093/jn/nxab404.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cardiovascular Diseases, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diabetes (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.