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

NCT ID: NCT04544527

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2031-12-31

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Complication Diabetic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoying Li, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Xuejian Ni

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaomu Li, MD

Role: CONTACT

li.xiaomu@zs-hospital.sh.cn

13661676591

References

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.

Reference Type: BACKGROUND

PMID: 9742976 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21551215 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32641435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18502303 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21505211 (View on PubMed)

Other Identifiers

ZSE-202002

Identifier Type: -

Identifier Source: org_study_id