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Clinical Trials/NCT04544527
NCT04544527
Recruiting
Not Applicable

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

Shanghai Zhongshan Hospital1 site in 1 country10,000 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Shanghai Zhongshan Hospital
Enrollment
10000
Locations
1
Primary Endpoint
MACE
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2031
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

MACE

Time Frame: 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

Time Frame: 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 Outcomes

  • chronic complications of diabetes(Up to 10 years)

Study Sites (1)

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