Tongji-Ezhou Study

NCT03845868 | Unknown DMC

• 1 other identifier: TJEZ2013
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Cardiovascular Diseases; Obesity; Metabolic Syndrome; Nutritional and Metabolic Diseases; Environmental Exposure; Risk Factor, Cardiovascular

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  5 years

• Diabetic complications

  Development of diabetic complications

  mean follow up of 10 years

• Incidence of cardiovascular diseases

  Cardiovascular death, stroke, myocardial infarction, heart failure

  mean follow up of 10 years

Study Arms (2)

Egang hospital physical examination center

Other: Dietary and environmental exposure (Observational study)

Ezhou CDC physical examination center

Other: Dietary and environmental exposure (Observational study)

Interventions

Dietary and environmental exposure (Observational study) OTHER

Egang hospital physical examination center; Ezhou CDC physical examination center

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

You may not qualify if:

• (i) with chemotherapy or radiotherapy for cancer and other severe diseases.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35091747 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and DNA were collected by clinicians during the morning after the examinees. Blood samples (5 ml) are collected with ethylenediamine tetra acetic acid anticoagulant tube from peripheral vessels. Plasma, buffy coat, and red blood cell layer are separated. The samples are stored at -80°C for future analyses. All bio-samples will be tracked through an electronic database.

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Obesity; Metabolic Syndrome; Nutritional and Metabolic Diseases

Interventions

Diet; Environmental Exposure; Observation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Environmental Pollution; Public Health; Environment and Public Health; Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice dean of School of Public Health, Tongji Medical College

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 19, 2019
• Study Start: April 16, 2013
• Primary Completion: January 31, 2019
• Study Completion: December 31, 2025
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

CN (1)