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

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ClinicalTrials.gov Identifier: NCT04544527
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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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
Diabetes Mellitus Cardiovascular Diseases Complication Diabetic

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
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Study Type : Observational
Estimated 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 : September 1, 2020
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2031
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. chronic complications of diabetes [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
blood sample, urinary sample.

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544527


Contacts
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Contact: Xiaomu Li, MD 13661676591 li.xiaomu@zs-hospital.sh.cn

Locations
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China, Jiangsu
Xuejian Ni Recruiting
Suzhou, Jiangsu, China
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Xiaoying Li, MD Fudan University
More Information
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Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04544527    
Other Study ID Numbers: ZSE-202002
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases