Diabetes MellitusHKDBNCT05282680
The Hong Kong Diabetes Biobank
An observational study of Diabetes Mellitus and Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes, Type 1 Diabetes
- What is being tested?
- prospective observational study
- How many people
- 48,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2014to Dec 2063
- How long will I take part?
- 99 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with known diabetes undergoing routine diabetes complications assessment at one of the designated and participating diabetes centres in Hong Kong.
Who may be able to join
- subjects with known diabetes
Who cannot join
- subjects not capable of giving written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrated Trans-omics Approach to Diabetic Cardio-renal Complications: From Novel Discoveries to Personalized Medicine Substudy 2: The Hong Kong Diabetes Biobank
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.
Read more
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.
Read the detailed description
The Hong Kong Diabetes Biobank leverages on the existing infrastructure of clinical assessment for people with diabetes.
Subjects undergoing routine diabetes complications screen at different diabetes centres across Hong Kong will be invited for recruitment into the Hong Kong Diabetes Biobank. Subjects will receive detailed information and explanation of the study, and written informed consent will be obtained from each subject interested in participating in the study.
As part of the routine diabetes complications assessment, all subjects will undergo a structured assessment based on the same protocol, including collection of background clinical information including demographics, diabetes duration, family history, medications and other relevant medical information. Anthropometric measurements including body weight, height, BMI will be collected. Clinical assessment include blood pressure, as well as fundus photography for assessment of diabetic retinopathy, and examination of peripheral pulses for peripheral vascular disease. Urine microalbumin will be measured using spot urine albumin/creatinine ratio. Other biochemical assessment include renal function, liver function, estimated GFR, fasting lipid profile, fasting glucose and HbA1c.
An additional 20ml blood will be obtained from each participating patient for extraction of genomic DNA, storage of serum, plasma, and for subsequent biomarker studies. Samples will be transported and processed for secure centralized storage at -80°C in dedicated facilities fitted with alarms. Samples will be identified by a unique assigned sample code. Selection and use of the samples for replication studies will be governed by the Steering Committee.
All recruited subjects will be prospectively followed up for development of diabetes complications and other clinical endpoints. Other clinical information and prescription records would be obtained from the electronic medical records.
Initial analyses would include identification of biomarkers associated with cardio-renal complications in diabetes. Subjects from the registry who have developed renal complications (diabetic kidney disease (DKD) defined as stage 3 chronic kidney disease or worse i.e. eGFR ≤60ml/min/1.73m2 and/or micro/macroalbuminuria) on prospective follow-up, will be compared to subjects free of kidney complications.
Subjects who developed cardiovascular complications (defined as new-onset acute coronary events, coronary revascularization, stroke and congestive cardiac failure) will be identified for a case: control analysis to replicate genetic predictors and other biomarkers associated with development of cardiovascular complications. Control subjects will be identified as subjects with type 2 diabetes who are free of cardiovascular events described above despite long duration of disease.
Other clinical outcomes of interest include diabetes progression and need for treatment intensification (including initiation of insulin treatment), as well as other clinical events.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes, Type 1 Diabetes, Diabetic Nephropathies, Diabetic Kidney Disease, Diabetic Angiopathies
- Being tested
- prospective observational study
- Keywords
- genetics, genomics, precision medicine, biomarkers, proteomics, epigenetics
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetic Nephropathies, Diabetic Angiopathies, Cardiovascular Diseases, Coronary Disease, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective observational studyOther
Also called biomarker assessment
prospective observational study
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Subjects with a diagnosis of type 2 diabetes Receives: Other: prospective observational study | |
| Type 1 diabetes | Subjects with a diagnosis of type 1 diabetes Receives: Other: prospective observational study | |
| Diabetic kidney disease | Subjects with diabetic kidney disease (presence of albuminuria +/- eGFR<=60m/kg/m2) or history or presence of end stage renal disease Receives: Other: prospective observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-99 years
Secondary outcomes (1)
Diabetes progression
Diabetes glycaemic progression will be defined as:
- progression to continuous insulin treatment (more than 6-months' duration), or
- failure of non-insulin diabetes treatment (two consecutive HbA1c ≥ target, more than 3-months apart during treatment with ≥2 non-insulin diabetes therapies.
Identification of genetic variants or other biomarkers associated with diabetes progression may utilize one or more of the above definitions.
Measured: 1-99 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Feb 2014
- Primary completionDec 2029 (estimated)
- Study completionDec 2063 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48,000 participants (estimated)
- Target duration
- 99 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Ronald C.W. Ma, Chinese University of Hong Kong
- Investigators
- Ronald C Ma, FRCP, Principal investigator, Department of Medicine and Therapeutics, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282680
- Sponsor's protocol ID
- 2013.304
- Other IDs
- T12-402/13N
- Acronym
- HKDB
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Trans-omics Approach to Diabetic Cardio-renal Complications: From Novel Discoveries to Personalized Medicine Substudy 2: The Hong Kong Diabetes Biobank
- ClinicalTrials.gov ID
- NCT05282680
- Acronym / sponsor ID
- HKDB / 2013.304
- Conditions
- Diabetes Mellitus, Type 2 Diabetes, Type 1 Diabetes, Diabetic Nephropathies, Diabetic Kidney Disease, Diabetic Angiopathies
- Keywords
- genetics, genomics, precision medicine, biomarkers, proteomics, epigenetics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 48,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2063 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Hong Kong Diabetes Biobank leverages on the existing infrastructure of clinical assessment for people with diabetes.
Subjects undergoing routine diabetes complications screen at different diabetes centres across Hong Kong will be invited for recruitment into the Hong Kong Diabetes Biobank. Subjects will receive detailed information and explanation of the study, and written informed consent will be obtained from each subject interested in participating in the study.
As part of the routine diabetes complications assessment, all subjects will undergo a structured assessment based on the same protocol, including collection of background clinical information including demographics, diabetes duration, family history, medications and other relevant medical information. Anthropometric measurements including body weight, height, BMI will be collected. Clinical assessment include blood pressure, as well as fundus photography for assessment of diabetic retinopathy, and examination of peripheral pulses for peripheral vascular disease. Urine microalbumin will be measured using spot urine albumin/creatinine ratio. Other biochemical assessment include renal function, liver function, estimated GFR, fasting lipid profile, fasting glucose and HbA1c.
An additional 20ml blood will be obtained from each participating patient for extraction of genomic DNA, storage of serum, plasma, and for subsequent biomarker studies. Samples will be transported and processed for secure centralized storage at -80°C in dedicated facilities fitted with alarms. Samples will be identified by a unique assigned sample code. Selection and use of the samples for replication studies will be governed by the Steering Committee.
All recruited subjects will be prospectively followed up for development of diabetes complications and other clinical endpoints. Other clinical information and prescription records would be obtained from the electronic medical records.
Initial analyses would include identification of biomarkers associated with cardio-renal complications in diabetes. Subjects from the registry who have developed renal complications (diabetic kidney disease (DKD) defined as stage 3 chronic kidney disease or worse i.e. eGFR ≤60ml/min/1.73m2 and/or micro/macroalbuminuria) on prospective follow-up, will be compared to subjects free of kidney complications.
Subjects who developed cardiovascular complications (defined as new-onset acute coronary events, coronary revascularization, stroke and congestive cardiac failure) will be identified for a case: control analysis to replicate genetic predictors and other biomarkers associated with development of cardiovascular complications. Control subjects will be identified as subjects with type 2 diabetes who are free of cardiovascular events described above despite long duration of disease.
Other clinical outcomes of interest include diabetes progression and need for treatment intensification (including initiation of insulin treatment), as well as other clinical events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 99 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | Other: prospective observational studySubjects with a diagnosis of type 2 diabetes |
| Type 1 diabetes | – | Other: prospective observational studySubjects with a diagnosis of type 1 diabetes |
| Diabetic kidney disease | – | Other: prospective observational studySubjects with diabetic kidney disease (presence of albuminuria +/- eGFR<=60m/kg/m2) or history or presence of end stage renal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with known diabetes undergoing routine diabetes complications assessment at one of the designated and participating diabetes centres in Hong Kong.
Key inclusion criteria (1 listed)
- subjects with known diabetes
Key exclusion criteria (1 listed)
- subjects not capable of giving written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective observational studyAlso: biomarker assessmentprospective observational study | Other | Diabetic kidney disease, Type 1 diabetes, Type 2 diabetes |
Primary outcome
Diabetic kidney disease
Time frame: 1-99 years
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.
Cardiovascular complications in diabetes
Time frame: 1-99 years
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 secondary outcome
Diabetes progression
Time frame: 1-99 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Website for Hong Kong Diabetes BiobankLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald C Ma, FRCP principal investigator
Department of Medicine and Therapeutics, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic kidney disease (time frame: 1-99 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.