Diabetic Complication Clinical Trial
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
Verified date | March 2022 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 435 |
Est. completion date | December 31, 2018 |
Est. primary completion date | April 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Adults with type 2 diabetes aged 40-75 who can give informed consent 2. Subjects with no known chronic kidney disease (CKD defined as eGFR<60ml/min at baseline) 3. Suboptimal glucose control with HbA1c = 7.5% 4. Known history of hypertension including elevated BP =140/90 on more than one occasion Exclusion Criteria: 1. Subjects with known coronary artery disease or coronary revascularisation 2. Subjects with previous history of cerebrovascular accident 3. Subjects with known proliferative retinopathy or previous laser treatment for diabetic retinopathy 4. Subjects with life-threatening conditions including malignancy 5. Subjects with known psychiatric conditions including depression 6. Subjects with significant renal impairment (eGFR<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy) 7. Subjects with major physical disability |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At 1 year | |
Secondary | microalbuminuria as a marker of degree of renal damage | new onset of microalbuminuria at 1 year follow-up | At 1 year | |
Secondary | Patient empowerment as measured on the Chinese Diabetes Empowerment Scale (DES) | Score on the DES | At 1 year | |
Secondary | Patient behavior measured on the Summary of Diabetes Self-care Activities (SDSCA) | Score of diabetes self-care as measured by the SDSCA | At 1 year |
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