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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04544527
Collaborator
(none)
10,000
1
136
73.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study
    Actual Study Start Date :
    Sep 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Dec 31, 2031

    Outcome Measures

    Primary Outcome Measures

    1. MACE [Up to 10 years]

      major adverse cardiovascular events,including the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.

    2. 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

    1. chronic complications of diabetes [Up to 10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xuejian Ni Suzhou Jiangsu China

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    • Principal Investigator: Xiaoying Li, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT04544527
    Other Study ID Numbers:
    • ZSE-202002
    First Posted:
    Sep 10, 2020
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 21, 2022