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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544527
• Other study ID #: ZSE-202002
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2031

Study information

• Verified date: December 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaomu Li, MD
• Phone: 13661676591
• Email: li.xiaomu[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Complication Diabetic
• Diabetes Complications
• Diabetes Mellitus

Locations

Country	Name	City	State
China	Xuejian Ni	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Anand SS, Dagenais GR, Mohan V, Diaz R, Probstfield J, Freeman R, Shaw J, Lanas F, Avezum A, Budaj A, Jung H, Desai D, Bosch J, Yusuf S, Gerstein HC; EpiDREAM Investigators. Glucose levels are associated with cardiovascular disease and death in an international cohort of normal glycaemic and dysglycaemic men and women: the EpiDREAM cohort study. Eur J Prev Cardiol. 2012 Aug;19(4):755-64. doi: 10.1177/1741826711409327. Epub 2011 May 6. — View Citation

Hu Y, Ding M, Sampson L, Willett WC, Manson JE, Wang M, Rosner B, Hu FB, Sun Q. Intake of whole grain foods and risk of type 2 diabetes: results from three prospective cohort studies. BMJ. 2020 Jul 8;370:m2206. doi: 10.1136/bmj.m2206. — View 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. — View Citation

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602. — View Citation

Li G, Zhang P, Wang J, Gregg EW, Yang W, Gong Q, Li H, Li H, Jiang Y, An Y, Shuai Y, Zhang B, Zhang J, Thompson TJ, Gerzoff RB, Roglic G, Hu Y, Bennett PH. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lancet. 2008 May 24;371(9626):1783-9. doi: 10.1016/S0140-6736(08)60766-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	major adverse cardiovascular events,including the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.	Up to 10 years
Primary	all-cause mortality	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	chronic complications of diabetes		Up to 10 years