NCT03299010

10-year Risk Prediction Models of Complications and Mortality of DM in Hong Kong

Completed Last updated 12 December 2024

What this trial tests

trial in Diabetes Mellitus in 141,516 participants. Completed in 31 December 2019.

Timeline

1 July 2017

Primary endpoint
31 December 2018

31 December 2019

Quick facts

Lead sponsor	The University of Hong Kong
Status	Completed
Study type	OBSERVATIONAL
Enrollment	141,516
Start date	1 July 2017
Primary completion	31 December 2018
Estimated completion	31 December 2019
Sites	2 locations across China, Hong Kong

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Mortality — all drugs for Mortality →
• Primary Health Care — all drugs for Primary Health Care →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Diabetes Mellitus or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetes Mellitus (DM) is a well-recognized public health issue worldwide. DM can lead to many complications resulting in morbidity and mortality, approximately 70% of DM related deaths were attributed to cardiovascular diseases (CVD).

Objectives:

To develop 10-year risk prediction models for CVD, end stage renal disease (ESRD) and all-cause mortality among Chinese patients with DM in primary care.

Hypotheses:

1. Patient socio-demographic, clinical parameters, disease characteristics and treatment modalities are predictive of 10-year risk of CVD, ESRD and all-cause mortality.
2. Risk prediction models developed from this study should have over 70% of discriminating power.

Design and Subjects:

10-year retrospective cohort study. All Chinese patients who were clinically diagnosed to have DM and were receiving care in the public (Hospital Authority) primary care clinics on or before 1 July 2006 will be followed up until 31 December 2016.

Main outcomes measures:

For total CVD, CHD, stroke, heart failure, ESRD, all-cause mortality

1. 10-year incidence;
2. Predictive factors

Data analysis:

Two thirds of subjects will be randomly selected as the training sample for model development. Cox regressions will be used to develop sex-specific 10-year risk prediction models for each outcome. The validity of models will be tested on the remaining one third of subjects by Harrell C statistics and ROC

Expected results:

Risk prediction models will enable accurate risk stratification and cost-effective interventions for Chinese DM patients in primary care.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Generative adversarial networks for imputing missing data for big data clinical research.
   Dong W, Fong DYT, Yoon JS, Wan EYF, et al · · 2021 · cited 28× · PMID 33879090 · DOI 10.1186/s12874-021-01272-3
2. Ten-year risk prediction models of complications and mortality of Chinese patients with diabetes mellitus in primary care in Hong Kong: a study protocol.
   Wan EYF, Yu EYT, Chin WY, Fung CSC, et al · · 2018 · cited 6× · PMID 30327405 · DOI 10.1136/bmjopen-2018-023070