An observational study in Diabetes Mellitus, Cardiovascular Diseases and Mortality, sponsored by The University of Hong Kong. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by The University of Hong Kong · Observational
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:
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
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.
This study aims to develop 10-year risk prediction models for total CVD and all-cause mortality among Chinese diabetic patients in primary care. Risk prediction models for individual DM complications including CHD, heart failure, stroke and ESRD will also be developed.
The objectives are to:
Hypotheses:
The cohort will include all patients with a documented clinical diagnosis of DM and were receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA clinical management system (CMS) database.
Exclusion Criteria:
Patients with a documented clinical diagnosis of DM and were receiving care in the Hospital Authority (HA) primary care General Out-Patient Clinics (GOPC) and Family Medicine Clinics (FMC) on or before 1 July 2006 identified from the HA clinical management system (CMS) database.
The incidence of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years
Calculate the 10 years incidence of total CVD, all-cause mortality and each major DM complication in Chinese DM patients in primary care. CVD is defined as the presence of any of CHD, heart failure and stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined by the ICPC-2 K77 or ICD-9-CM 428.x. Stoke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.
Time frame: 10 years
Factors predictive of total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD) over 10 years
Determine the risk factors that significantly predict total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
Time frame: 10 years
10-year risk prediction models for total CVD, all-cause mortality and each of 4 major DM complications (CHD, stroke, heart failure and ESRD)
Develop and validate risk prediction models for total CVD, all-cause mortality and each major DM complication for Chinese DM patients in primary care.
Time frame: 10 years
Factors that have sufficient power to classify Chinese DM patients in primary care into risk group in terms of total CVD and all-cause mortality
Develop a risk prediction nomogram and chart for the risk of total CVD, all-cause mortality for Chinese DM patients in primary care
Time frame: 10 years
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong