Diabetic ComplicationNCT02364323
Genetic Testing and Counseling to Reduce Diabetic Complications
A study testing Personalized Risk Counselling in people with Diabetic Complication, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The risk of diabetic kidney complications includes non-modifiable risk factors such as genetic predictors, as well as modifiable risk factors such as hyperglycaemia, hypertension, hyperlipidaemia and proteinuria. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Complication
- What is being tested?
- Personalized Risk Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 435 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Feb 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with type 2 diabetes aged 40-75 who can give informed consent
- Subjects with no known chronic kidney disease (CKD defined as eGFR<60ml/min at baseline)
- Suboptimal glucose control with HbA1c ≥ 7.5%
- Known history of hypertension including elevated BP ≥140/90 on more than one occasion
Who cannot join
- Subjects with known coronary artery disease or coronary revascularisation
- Subjects with previous history of cerebrovascular accident
- Subjects with known proliferative retinopathy or previous laser treatment for diabetic retinopathy
- Subjects with life-threatening conditions including malignancy
- Subjects with known psychiatric conditions including depression
- Subjects with significant renal impairment (eGFR<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy)
- Subjects with major physical disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial to Compare a Strategy Utilizing Genetic Testing and Personalized Risk Counseling With Standard Care on Patient Empowerment, Risk Factors Control and the Risk of Diabetic Complications
The risk of diabetic kidney complications includes non-modifiable risk factors such as genetic predictors, as well as modifiable risk factors such as hyperglycaemia, hypertension, hyperlipidaemia and proteinuria. Genetic testing for personalized medicine is increasing in popularity, though evidence that genetic testing can empower patients to modify behaviour and reduce clinical risk remains lacking. In this project, the investigators aim to utilize a personalized risk counseling with genetic testing to evaluate its impact on risk factor control in diabetic patients. The investigators hypothesize that knowledge of genetic +/- clinical risk will empower patients and lead to improvement in the number of treatment targets achieved. The investigators will recruit 400 patients with diabetes. All subjects will undergo a comprehensive assessment of the risk of diabetic complications based on clinical risk factors. Half of the patients will be randomized to receive additional genetic testing of a panel of genetic markers proven to predict renal complications in our population: ACE I/D, aldose reductase (CA)n and PRKCB1 gene polymorphisms. The results of personalized risk assessment will be communicated by a health counsellor in the intervention arm. The impact of testing and patient knowledge of the result of genetic testing on achievement of treatment targets (A1c, BP, LDL-cholesterol, TG, use of ACEI/ARB) and patient behavior will be evaluated after 12 months. The other arm will receive results of the genetic testing at the completion of the study period. The study will help towards developing a strategy to empower patients through structured and personalized risk assessment will provide a novel approach to identify high-risk subjects for early intensive management, and may lead to reduction in long-term complications.
Read the detailed description
Asia is in the midst of an epidemic of diabetes. Approximately 1 in 10 people in China has diabetes [1]. Asian patients with diabetes are characterized by early age of onset and increased risk of kidney complications. Young age of onset and long disease duration will place Chinese diabetic patients at high risk for complications. In the Hong Kong Diabetes Registry, which includes more than 7000 patients with type 2 diabetes, we have reported a high risk of diabetic complications, with 30% having died or sustained a major clinical event within 10years after diagnosis, including 10% developing cardiovascular complications, and 10% developing end-stage renal disease [2] [3]. The medical costs for the diabetic patient with complication is 2.2-3.8 fold that of patients without complications, and patients with cardiorenal complications are the most costly to manage [4]. Using our registry, we have identified clinical risk predictors for developing renal complications as glycaemic control, elevated blood pressure, hyperlipidaemia, and albuminuria [2] [3, 5], and have derived clinical risk prediction algorithms and incorporated them into a patient management portal, which can generate a standardized report for risk counseling based on clinical risk factors [6, 7]. Furthermore, in a multi-centre study utilizing a multidisciplinary team, we found that intensive management aiming to achieve targets of A1c, lipids, BP can significantly reduce the risk of developing kidney complication [8]. Therefore, the ability to identify subjects at risk of complications, and to target and motivate them to optimize modifiable risk factors for diabetic complications will be of clinical benefit and potentially cost-saving.
There has been much recent interest in the use of genetic testing for personalized medicine [9]. Diabetic kidney complications has high heritability of around 40% and several genetic factors have been found to be associated with diabetic renal complications. Using candidate-gene approach, our group has identified several genetic markers for diabetic kidney complications [10, 11] [12]. These include the angiotensin converting enzyme deletion/ insertion (ACE D/I) polymorphism and the aldose reductase (ALR2) 5'-(CA) n microsatellite polymorphism, each being associated with 2-3 fold increased risk of diabetic cardio-renal complications in Chinese [10, 13]. More recently, we have found that carriers of risk alleles at the protein kinase C-β1 (PRKCB1) locus can have up to 6-fold increased risk of developing end-stage renal disease during follow-up, after adjusting for the effect of clinical risk predictors [12].
The recent increase in consumer-initiated genetic testing has been driven by direct-to-consumer genetic testing, which assumes that personal genetic information can motivate positive behavioural change in patients [14]. Interestingly, a recent survey of patients without type 2 diabetes suggests that genetic testing may be able to motivate patients, with 71% of respondents reporting that they would be "much more motivated" to make behavioural changes if they were informed to be of high genetic risk for diabetes [15]. Although evidence that genetic testing can lead to behavioural changes is still lacking, several randomized clinical trials are currently underway to examine the impact of genetic testing on behaviour to reduce risk of diabetes. Given the disabling consequences of diabetic complications, and the ability to predict those at risk of developing complications, we plan to examine the role of personalized risk counseling incorporating genetic markers, and to examine its role in patient empowerment and risk factor control, which may help to reduce the risk of developing complications.
- Conditions
- Diabetic Complication
- Being tested
- Personalized Risk Counselling, Normal usual care
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Risk CounsellingBehavioural
Motivational message- towards lifestyle change, improved compliance and risk factors control Review overall control of clinical risk factors based on lab test results
Normal usual careOther
General education on diabetes and diabetic complications
| Study group | Role | What they receive |
|---|---|---|
| Personalized risk counselling | Experimental | Intervention includes risk counseling to patients with diabetes on future risk of diabetic complications based on an established genetic counseling framework for common polygenic disorders which will be delivered to patient in a counselling sesssion 6 weeks after genetic testing Receives: Behavioral: Personalized Risk Counselling |
| Normal usual care | Placebo comparator | Intervention includes normal usual care. General education on diabetes and diabetic complications Receives: Other: Normal usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients attaining ≥ 3 pre-defined treatment targets from the following treatment targets: 1) BP <130/80 mm Hg 2) HbA1c <7% 3) Calculated LDL-cholesterol <2.6mmol/l 4) Fasting TG <2mmol/l 5) Use of ACEI or ARB
primary outcome of 3 out of 5 targets achieved as defined above
Measured: At 1 year
Secondary outcomes (3)
microalbuminuria as a marker of degree of renal damage
new onset of microalbuminuria at 1 year follow-up
Measured: At 1 year
Patient empowerment as measured on the Chinese Diabetes Empowerment Scale (DES)
Score on the DES
Measured: At 1 year
Patient behavior measured on the Summary of Diabetes Self-care Activities (SDSCA)
Score of diabetes self-care as measured by the SDSCA
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start17 Feb 2015
- Primary completion18 Apr 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Diabetic ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 435 participants (actual)
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, MB BChir, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364323
- Sponsor's protocol ID
- GEM Study
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2015
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
PubMed 20335585Chan JC, So W, Ma RC, Tong PC, Wong R, Yang X. The Complexity of Vascular and Non-Vascular Complications of Diabetes: The Hong Kong Diabetes Registry. Curr Cardiovasc Risk Rep. 2011 Jun;5(3):230-239. doi: 10.1007/s12170-011-0172-6. Epub 2011 Apr 12.
PubMed 21654912Yang XL, So WY, Kong AP, Clarke P, Ho CS, Lam CW, Ng MH, Lyu RR, Yin DD, Chow CC, Cockram CS, Tong PC, Chan JC. End-stage renal disease risk equations for Hong Kong Chinese patients with type 2 diabetes: Hong Kong Diabetes Registry. Diabetologia. 2006 Oct;49(10):2299-308. doi: 10.1007/s00125-006-0376-3. Epub 2006 Aug 30.
PubMed 16944095Chan BS, Tsang MW, Lee VW, Lee KK. Cost of Type 2 Diabetes mellitus in Hong Kong Chinese. Int J Clin Pharmacol Ther. 2007 Aug;45(8):455-68. doi: 10.5414/cpp45455.
PubMed 17725179Luk AO, So WY, Ma RC, Kong AP, Ozaki R, Ng VS, Yu LW, Lau WW, Yang X, Chow FC, Chan JC, Tong PC; Hong Kong Diabetes Registry. Metabolic syndrome predicts new onset of chronic kidney disease in 5,829 patients with type 2 diabetes: a 5-year prospective analysis of the Hong Kong Diabetes Registry. Diabetes Care. 2008 Dec;31(12):2357-61. doi: 10.2337/dc08-0971. Epub 2008 Oct 3.
PubMed 18835954Chan J, So W, Ko G, Tong P, Yang X, Ma R, Kong A, Wong R, Le Coguiec F, Tamesis B, Wolthers T, Lyubomirsky G, Chow P. The Joint Asia Diabetes Evaluation (JADE) Program: a web-based program to translate evidence to clinical practice in Type 2 diabetes. Diabet Med. 2009 Jul;26(7):693-9. doi: 10.1111/j.1464-5491.2009.02751.x.
PubMed 19573118Ko GT, So WY, Tong PC, Le Coguiec F, Kerr D, Lyubomirsky G, Tamesis B, Wolthers T, Nan J, Chan J. From design to implementation--the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program. BMC Med Inform Decis Mak. 2010 May 13;10:26. doi: 10.1186/1472-6947-10-26.
PubMed 20465815Chan JC, So WY, Yeung CY, Ko GT, Lau IT, Tsang MW, Lau KP, Siu SC, Li JK, Yeung VT, Leung WY, Tong PC; SURE Study Group. Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study. Diabetes Care. 2009 Jun;32(6):977-82. doi: 10.2337/dc08-1908.
PubMed 19460913Malandrino N, Smith RJ. Personalized medicine in diabetes. Clin Chem. 2011 Feb;57(2):231-40. doi: 10.1373/clinchem.2010.156901. Epub 2010 Dec 2.
PubMed 21127150Wang Y, Ng MC, So WY, Tong PC, Ma RC, Chow CC, Cockram CS, Chan JC. Prognostic effect of insertion/deletion polymorphism of the ace gene on renal and cardiovascular clinical outcomes in Chinese patients with type 2 diabetes. Diabetes Care. 2005 Feb;28(2):348-54. doi: 10.2337/diacare.28.2.348.
PubMed 15677791Wang Y, Luk AO, Ma RC, So WY, Tam CH, Ng MC, Yang X, Lam V, Tong PC, Chan JC. Predictive role of multilocus genetic polymorphisms in cardiovascular disease and inflammation-related genes on chronic kidney disease in Type 2 diabetes--an 8-year prospective cohort analysis of 1163 patients. Nephrol Dial Transplant. 2012 Jan;27(1):190-6. doi: 10.1093/ndt/gfr343. Epub 2011 Jul 15.
PubMed 21765051Ma RC, Tam CH, Wang Y, Luk AO, Hu C, Yang X, Lam V, Chan AW, Ho JS, Chow CC, Tong PC, Jia W, Ng MC, So WY, Chan JC. Genetic variants of the protein kinase C-beta 1 gene and development of end-stage renal disease in patients with type 2 diabetes. JAMA. 2010 Aug 25;304(8):881-9. doi: 10.1001/jama.2010.1191.
PubMed 20736472So WY, Wang Y, Ng MC, Yang X, Ma RC, Lam V, Kong AP, Tong PC, Chan JC. Aldose reductase genotypes and cardiorenal complications: an 8-year prospective analysis of 1,074 type 2 diabetic patients. Diabetes Care. 2008 Nov;31(11):2148-53. doi: 10.2337/dc08-0712. Epub 2008 Aug 20.
PubMed 18716049Janssens AC, Gwinn M, Bradley LA, Oostra BA, van Duijn CM, Khoury MJ. A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions. Am J Hum Genet. 2008 Mar;82(3):593-9. doi: 10.1016/j.ajhg.2007.12.020.
PubMed 18319070Grant RW, Hivert M, Pandiscio JC, Florez JC, Nathan DM, Meigs JB. The clinical application of genetic testing in type 2 diabetes: a patient and physician survey. Diabetologia. 2009 Nov;52(11):2299-2305. doi: 10.1007/s00125-009-1512-7. Epub 2009 Sep 2.
PubMed 19727660
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Compare a Strategy Utilizing Genetic Testing and Personalized Risk Counseling With Standard Care on Patient Empowerment, Risk Factors Control and the Risk of Diabetic Complications
- ClinicalTrials.gov ID
- NCT02364323
- Acronym / sponsor ID
- GEM Study
- Conditions
- Diabetic Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Feb 2015 (estimated)
- 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.
The risk of diabetic kidney complications includes non-modifiable risk factors such as genetic predictors, as well as modifiable risk factors such as hyperglycaemia, hypertension, hyperlipidaemia and proteinuria. Genetic testing for personalized medicine is increasing in popularity, though evidence that genetic testing can empower patients to modify behaviour and reduce clinical risk remains lacking. In this project, the investigators aim to utilize a personalized risk counseling with genetic testing to evaluate its impact on risk factor control in diabetic patients. The investigators hypothesize that knowledge of genetic +/- clinical risk will empower patients and lead to improvement in the number of treatment targets achieved. The investigators will recruit 400 patients with diabetes. All subjects will undergo a comprehensive assessment of the risk of diabetic complications based on clinical risk factors. Half of the patients will be randomized to receive additional genetic testing of a panel of genetic markers proven to predict renal complications in our population: ACE I/D, aldose reductase (CA)n and PRKCB1 gene polymorphisms. The results of personalized risk assessment will be communicated by a health counsellor in the intervention arm. The impact of testing and patient knowledge of the result of genetic testing on achievement of treatment targets (A1c, BP, LDL-cholesterol, TG, use of ACEI/ARB) and patient behavior will be evaluated after 12 months. The other arm will receive results of the genetic testing at the completion of the study period. The study will help towards developing a strategy to empower patients through structured and personalized risk assessment will provide a novel approach to identify high-risk subjects for early intensive management, and may lead to reduction in long-term complications.
Detailed description
Asia is in the midst of an epidemic of diabetes. Approximately 1 in 10 people in China has diabetes [1]. Asian patients with diabetes are characterized by early age of onset and increased risk of kidney complications. Young age of onset and long disease duration will place Chinese diabetic patients at high risk for complications. In the Hong Kong Diabetes Registry, which includes more than 7000 patients with type 2 diabetes, we have reported a high risk of diabetic complications, with 30% having died or sustained a major clinical event within 10years after diagnosis, including 10% developing cardiovascular complications, and 10% developing end-stage renal disease [2] [3]. The medical costs for the diabetic patient with complication is 2.2-3.8 fold that of patients without complications, and patients with cardiorenal complications are the most costly to manage [4]. Using our registry, we have identified clinical risk predictors for developing renal complications as glycaemic control, elevated blood pressure, hyperlipidaemia, and albuminuria [2] [3, 5], and have derived clinical risk prediction algorithms and incorporated them into a patient management portal, which can generate a standardized report for risk counseling based on clinical risk factors [6, 7]. Furthermore, in a multi-centre study utilizing a multidisciplinary team, we found that intensive management aiming to achieve targets of A1c, lipids, BP can significantly reduce the risk of developing kidney complication [8]. Therefore, the ability to identify subjects at risk of complications, and to target and motivate them to optimize modifiable risk factors for diabetic complications will be of clinical benefit and potentially cost-saving.
There has been much recent interest in the use of genetic testing for personalized medicine [9]. Diabetic kidney complications has high heritability of around 40% and several genetic factors have been found to be associated with diabetic renal complications. Using candidate-gene approach, our group has identified several genetic markers for diabetic kidney complications [10, 11] [12]. These include the angiotensin converting enzyme deletion/ insertion (ACE D/I) polymorphism and the aldose reductase (ALR2) 5'-(CA) n microsatellite polymorphism, each being associated with 2-3 fold increased risk of diabetic cardio-renal complications in Chinese [10, 13]. More recently, we have found that carriers of risk alleles at the protein kinase C-β1 (PRKCB1) locus can have up to 6-fold increased risk of developing end-stage renal disease during follow-up, after adjusting for the effect of clinical risk predictors [12].
The recent increase in consumer-initiated genetic testing has been driven by direct-to-consumer genetic testing, which assumes that personal genetic information can motivate positive behavioural change in patients [14]. Interestingly, a recent survey of patients without type 2 diabetes suggests that genetic testing may be able to motivate patients, with 71% of respondents reporting that they would be "much more motivated" to make behavioural changes if they were informed to be of high genetic risk for diabetes [15]. Although evidence that genetic testing can lead to behavioural changes is still lacking, several randomized clinical trials are currently underway to examine the impact of genetic testing on behaviour to reduce risk of diabetes. Given the disabling consequences of diabetic complications, and the ability to predict those at risk of developing complications, we plan to examine the role of personalized risk counseling incorporating genetic markers, and to examine its role in patient empowerment and risk factor control, which may help to reduce the risk of developing complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized risk counselling | Experimental | Behavioral: Personalized Risk CounsellingIntervention includes risk counseling to patients with diabetes on future risk of diabetic complications based on an established genetic counseling framework for common polygenic disorders which will be delivered to patient in a counselling sesssion 6 weeks after genetic testing |
| Normal usual care | Placebo comparator | Other: Normal usual careIntervention includes normal usual care. General education on diabetes and diabetic complications |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with type 2 diabetes aged 40-75 who can give informed consent
- Subjects with no known chronic kidney disease (CKD defined as eGFR<60ml/min at baseline)
- Suboptimal glucose control with HbA1c ≥ 7.5%
- Known history of hypertension including elevated BP ≥140/90 on more than one occasion
Key exclusion criteria (7 listed)
- Subjects with known coronary artery disease or coronary revascularisation
- Subjects with previous history of cerebrovascular accident
- Subjects with known proliferative retinopathy or previous laser treatment for diabetic retinopathy
- Subjects with life-threatening conditions including malignancy
- Subjects with known psychiatric conditions including depression
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 |
|---|---|---|
| Personalized Risk CounsellingMotivational message- towards lifestyle change, improved compliance and risk factors control Review overall control of clinical risk factors based on lab test results | Behavioural | Personalized risk counselling |
| Normal usual careGeneral education on diabetes and diabetic complications | Other | Normal usual care |
Primary outcome
percentage of patients attaining ≥ 3 pre-defined treatment targets from the following treatment targets: 1) BP <130/80 mm Hg 2) HbA1c <7% 3) Calculated LDL-cholesterol <2.6mmol/l 4) Fasting TG <2mmol/l 5) Use of ACEI or ARB
Time frame: At 1 year
primary outcome of 3 out of 5 targets achieved as defined above
3 secondary outcomes
microalbuminuria as a marker of degree of renal damage
Time frame: At 1 year
Patient empowerment as measured on the Chinese Diabetes Empowerment Scale (DES)
Time frame: At 1 year
Patient behavior measured on the Summary of Diabetes Self-care Activities (SDSCA)
Time frame: At 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Background: PubMed 20335585Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
- Background: PubMed 21654912Chan JC, So W, Ma RC, Tong PC, Wong R, Yang X. The Complexity of Vascular and Non-Vascular Complications of Diabetes: The Hong Kong Diabetes Registry. Curr Cardiovasc Risk Rep. 2011 Jun;5(3):230-239. doi: 10.1007/s12170-011-0172-6. Epub 2011 Apr 12.
- Background: PubMed 16944095Yang XL, So WY, Kong AP, Clarke P, Ho CS, Lam CW, Ng MH, Lyu RR, Yin DD, Chow CC, Cockram CS, Tong PC, Chan JC. End-stage renal disease risk equations for Hong Kong Chinese patients with type 2 diabetes: Hong Kong Diabetes Registry. Diabetologia. 2006 Oct;49(10):2299-308. doi: 10.1007/s00125-006-0376-3. Epub 2006 Aug 30.
- Background: PubMed 17725179Chan BS, Tsang MW, Lee VW, Lee KK. Cost of Type 2 Diabetes mellitus in Hong Kong Chinese. Int J Clin Pharmacol Ther. 2007 Aug;45(8):455-68. doi: 10.5414/cpp45455.
- Background: PubMed 18835954Luk AO, So WY, Ma RC, Kong AP, Ozaki R, Ng VS, Yu LW, Lau WW, Yang X, Chow FC, Chan JC, Tong PC; Hong Kong Diabetes Registry. Metabolic syndrome predicts new onset of chronic kidney disease in 5,829 patients with type 2 diabetes: a 5-year prospective analysis of the Hong Kong Diabetes Registry. Diabetes Care. 2008 Dec;31(12):2357-61. doi: 10.2337/dc08-0971. Epub 2008 Oct 3.
- Background: PubMed 19573118Chan J, So W, Ko G, Tong P, Yang X, Ma R, Kong A, Wong R, Le Coguiec F, Tamesis B, Wolthers T, Lyubomirsky G, Chow P. The Joint Asia Diabetes Evaluation (JADE) Program: a web-based program to translate evidence to clinical practice in Type 2 diabetes. Diabet Med. 2009 Jul;26(7):693-9. doi: 10.1111/j.1464-5491.2009.02751.x.
- Background: PubMed 20465815Ko GT, So WY, Tong PC, Le Coguiec F, Kerr D, Lyubomirsky G, Tamesis B, Wolthers T, Nan J, Chan J. From design to implementation--the Joint Asia Diabetes Evaluation (JADE) program: a descriptive report of an electronic web-based diabetes management program. BMC Med Inform Decis Mak. 2010 May 13;10:26. doi: 10.1186/1472-6947-10-26.
- Background: PubMed 19460913Chan JC, So WY, Yeung CY, Ko GT, Lau IT, Tsang MW, Lau KP, Siu SC, Li JK, Yeung VT, Leung WY, Tong PC; SURE Study Group. Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study. Diabetes Care. 2009 Jun;32(6):977-82. doi: 10.2337/dc08-1908.
- Background: PubMed 21127150Malandrino N, Smith RJ. Personalized medicine in diabetes. Clin Chem. 2011 Feb;57(2):231-40. doi: 10.1373/clinchem.2010.156901. Epub 2010 Dec 2.
- Background: PubMed 15677791Wang Y, Ng MC, So WY, Tong PC, Ma RC, Chow CC, Cockram CS, Chan JC. Prognostic effect of insertion/deletion polymorphism of the ace gene on renal and cardiovascular clinical outcomes in Chinese patients with type 2 diabetes. Diabetes Care. 2005 Feb;28(2):348-54. doi: 10.2337/diacare.28.2.348.
- Background: PubMed 21765051Wang Y, Luk AO, Ma RC, So WY, Tam CH, Ng MC, Yang X, Lam V, Tong PC, Chan JC. Predictive role of multilocus genetic polymorphisms in cardiovascular disease and inflammation-related genes on chronic kidney disease in Type 2 diabetes--an 8-year prospective cohort analysis of 1163 patients. Nephrol Dial Transplant. 2012 Jan;27(1):190-6. doi: 10.1093/ndt/gfr343. Epub 2011 Jul 15.
- Background: PubMed 20736472Ma RC, Tam CH, Wang Y, Luk AO, Hu C, Yang X, Lam V, Chan AW, Ho JS, Chow CC, Tong PC, Jia W, Ng MC, So WY, Chan JC. Genetic variants of the protein kinase C-beta 1 gene and development of end-stage renal disease in patients with type 2 diabetes. JAMA. 2010 Aug 25;304(8):881-9. doi: 10.1001/jama.2010.1191.
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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, MB BChir principal investigator
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?
A study testing Personalized Risk Counselling in people with Diabetic Complication, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 21 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of patients attaining ≥ 3 pre-defined treatment targets from the following treatment targets: 1) BP <130/80 mm Hg 2) HbA1c <7% 3) Calculated LDL-cholesterol <2.6mmol/l 4) Fasting TG <2mmol/l 5) Use of ACEI or ARB (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02364323, which also lists 18 linked publications.
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 21 Mar 2022.