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

January 20, 2022 updated by: Shanghai Zhongshan Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • Xuejian Ni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 communities.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 10 years
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.
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
chronic complications of diabetes
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2031

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSE-202002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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