The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study

Recruiting

• Conditions: Cardiovascular Diseases; Complication Diabetic; Diabetes Mellitus

• Registration Number: NCT04544527
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

In the previous cohort studies focused on diabetes in China, there were few studies on elderly patients with diabetes. The aim of this prospective cohort study was to investigate the prevalence, management and nutritional status of elderly diabetic patients aged ≥65 years in Shanghai and Suzhou communities, and record the occurrence of endpoint events.

Detailed Description

This is a multicenter, observational, prospective cohort study.We plan to collect the baseline information in three years, and follow up every two years for at least 10 years. The study will enroll 5000 elderly diabetic patients aged ≥65 years and be conducted in Shanghai and Suzhou. The primary outcomes include MACE(major adverse cardiovascular events) , all-cause mortality, and chronic complications of diabetes and so on.

Study Timeline

• Study First Submitted: 2020-07-21
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-10
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Men or women aged 65-100 years old;
• Patients who had been diagnosed with diabetes mellitus.

Exclusion Criteria

• Patients with psychiatric disorders or impaired cognitive function;
• Patients who cannot or reject to sign the consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	Up to 10 years	major adverse cardiovascular events,including the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.
all-cause mortality	Up to 10 years	All-cause mortality was confrmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Xiangcheng Center for Disease Control and Prevention.

Secondary Outcome Measures

Name	Time	Method
chronic complications of diabetes	Up to 10 years

Trial Locations

Locations (1)

Xuejian Ni; 🇨🇳 Suzhou, Jiangsu, China