The Hong Kong Diabetes Biobank
HKDB
An Integrated Trans-omics Approach to Diabetic Cardio-renal Complications: From Novel Discoveries to Personalized Medicine Substudy 2: The Hong Kong Diabetes Biobank
2 other identifiers
observational
48,000
1 country
1
Brief Summary
Asia is in the midst of an epidemic of diabetes. Epidemiological figures suggest that there are more than 110 million people affected by diabetes in China, with a significant proportion of young adults already affected. With increasingly young age of onset, the financial implications due to productivity loss and health care expenditures are colossal. As a result, prevention of diabetes and diabetic complications has been identified as a top healthcare priority in China. In Chinese, diabetic kidney disease with albuminuria, which reflects widespread vascular damage, is a major predictor for end-stage renal failure, cardiovascular complications and death, and a major contributor to the increased healthcare burden associated with diabetes. There is an immense demand for effective tools which can accurately predict diabetes and diabetic complications. Only few genetic factors have been consistently shown to be associated with diabetic kidney disease or other diabetic complications. Identification of genetic factors or other biomarkers predicting these complications can facilitate early identification of high risk subjects for treatment, as well as provide novel targets for drug treatment. To address this, the investigators plan to utilize both hypothesis-generating whole-genome approach as well as candidate gene-based studies to identify novel genetic, epigenetic factors as well as other biomarkers associated with the development of diabetic cardiovascular and renal complications, as well as other diabetes-related outcomes. The Hong Kong Diabetes Biobank (HKDB) is being established in order to serve as a territory-wide diabetes register and biobank for epidemiological analyses, as well as large-scale discovery and replication of genetic and epigenetic markers, and other biomarkers relating to diabetes, diabetes complications or related outcomes. Subjects will be recruited from diabetes centres across Hong Kong, and will have detailed clinical information collected at the time of written consent and blood taking. Subjects will have detailed assessment of baseline diabetes complications through a structured clinical assessment, and will be prospectively followed up for development of different diabetes-related endpoints, as well as collection of clinical information and causes of hospitalization, along with information on medications and prescription records. This multi-centre cohort and biobank aims to improve our understanding of the epidemiology of diabetes and diabetes complications and related outcomes, as well as provide a unique resource for large-scale biomarker research to advance diabetes care and precision medicine in diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2063
March 12, 2026
March 1, 2026
15.8 years
February 28, 2022
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Diabetic kidney disease
Diabetic kidney disease will be defined as: eGFR \<60 ml/min per 1.73 m2. +/- presence of elevated urine microalbumin Other hospital discharge diagnoses based on eGFR or ICD-9 codes or other equivalent will be used. Kidney failure/end stage renal disease (ESRD) will be defined by the presence of a dialysis code (procedure codes 39.95 or 54.98), a code of kidney transplant (procedure code 55.6 or diagnosis codes 996.81 or V42.0), or eGFR \<15 ml/min per1.73 m2. The onset time will be defined as the period from baseline visit to the date of kidney failure onset or the censored date, whichever came first. The rate of decline in eGFR and % drop in eGFR, as well as changes in urine albuminuria will also be explored as additional clinical endpoints in diabetic kidney disease. Identification of genetic variants or other biomarkers associated with diabetic kidney disease by association analyses may utilize one or more of the clinical definitions of diabetic kidney disease.
1-99 years
Cardiovascular complications in diabetes
Cardiovascular complications in diabetes will be defined as coronary heart disease (CHD), stroke, and/or peripheral vascular disease (PVD), and/or congestive heart failure. Coronary Heart Disease is defined as myocardial infarction, ischemic heart disease, or cardiac revascularisation. Stroke is defined as ischemic stroke except transient ischemic attack, hemorrhagic stroke, or acute but ill-defined cerebrovascular disease Peripheral vascular disease is defined as amputation, gangrene, or peripheral revascularization. Hospitalization for heart failure is defined as hospitalization for congestive heart failure. Identification of genetic variants or other biomarkers associated with cardiovascular disease in diabetes may utilize one or more of the clinical definitions of cardiovascular complications in diabetes.
1-99 years
Secondary Outcomes (1)
Diabetes progression
1-99 years
Study Arms (3)
Type 2 diabetes
Subjects with a diagnosis of type 2 diabetes
Type 1 diabetes
Subjects with a diagnosis of type 1 diabetes
Diabetic kidney disease
Subjects with diabetic kidney disease (presence of albuminuria +/- eGFR\<=60m/kg/m2) or history or presence of end stage renal disease
Interventions
prospective observational study
Eligibility Criteria
Subjects with known diabetes undergoing routine diabetes complications assessment at one of the designated and participating diabetes centres in Hong Kong.
You may qualify if:
- subjects with known diabetes
You may not qualify if:
- subjects not capable of giving written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Shatin, Hong Kong
Related Links
Biospecimen
The following biospecimens are collected: whole blood for extraction of DNA, serum, plasma. Types of omics data currently being generated include genotyping data, metabolomic, proteins and other biomarker data
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald C Ma, FRCP
Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 99 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 16, 2022
Study Start
February 1, 2014
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2063
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share