Clinical trial NCT04544527: The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study
Official title: The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Cardiovascular Diseases
Complication Diabetic
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: MACE
timeFrame: Up to 10 years
measure: all-cause mortality
timeFrame: Up to 10 years
Secondary outcomes:
measure: chronic complications of diabetes
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Xuejian Ni
state: Jiangsu
Study officials:
affiliation: Fudan University
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Huang ES, Liu JY, Moffet HH, John PM, Karter AJ. Glycemic control, complications, and death in older diabetic patients: the diabetes and aging study. Diabetes Care. 2011 Jun;34(6):1329-36. doi: 10.2337/dc10-2377. Epub 2011 Apr 19.