NCT04544527

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2020Dec 2031

First Submitted

Initial submission to the registry

July 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

January 21, 2022

Status Verified

December 1, 2021

Enrollment Period

10.3 years

First QC Date

July 21, 2020

Last Update Submit

January 20, 2022

Conditions

Diabetes MellitusCardiovascular DiseasesComplication Diabetic

Outcome Measures

Primary Outcomes (2)

  • MACE

    major adverse cardiovascular events,including the first occurrence of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.

    Up to 10 years

  • 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 Outcomes (1)

  • chronic complications of diabetes

    Up to 10 years

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Men or women aged 65-100 years old;
  • Patients who had been diagnosed with diabetes mellitus.

You may not qualify if:

  • Patients with psychiatric disorders or impaired cognitive function;
  • Patients who cannot or reject to sign the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuejian Ni

Suzhou, Jiangsu, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 9742976BACKGROUND

  • 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.

    PMID: 21551215BACKGROUND

  • 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.

    PMID: 32641435BACKGROUND

  • 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.

    PMID: 18502303BACKGROUND

  • 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.

    PMID: 21505211BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample, urinary sample.

MeSH Terms

Conditions

Diabetes MellitusCardiovascular DiseasesDiabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Xiaoying Li, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomu Li, MD

CONTACT

13661676591li.xiaomu@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2020

First Posted

September 10, 2020

Study Start

September 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

January 21, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)