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NCT Number: NCT04544527

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

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Complication Diabetic Diabetes Complications Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuejian Ni

Suzhou, Jiangsu, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. chronic complications of diabetes

    Time frame: Up to 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaomu Li, MD

CONTACT

[email protected]

13661676591

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Sep 10, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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