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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04544527

Enrollment

10000

Registered

2020-09-10

Start date

2020-09-01

Completion date

2031-12-31

Last updated

2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Complication Diabetic, Diabetes Mellitus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
chronic complications of diabetes	Up to 10 years

Countries

China

Contacts

Primary ContactXiaomu Li, MD

li.xiaomu@zs-hospital.sh.cn13661676591

Outcome results