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NCT02364323

Genetic Testing and Counseling to Reduce Diabetic Complications

Completed NA Last updated 21 March 2022
What this trial tests

NA trial testing Personalized Risk Counselling in Diabetic Complication in 435 participants. Completed in 31 December 2018.

Timeline
17 February 2015
Primary endpoint
18 April 2017
31 December 2018

Quick facts

Lead sponsorChinese University of Hong Kong
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposehealth services research
Enrollment435
Start date17 February 2015
Primary completion18 April 2017
Estimated completion31 December 2018
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Chinese University of Hong Kong

Who can join

Adults 40 to 75, any sex, with Diabetic Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Diabetic Complication

Currently open trials in the same condition.

Other Chinese University of Hong Kong trials

Trials by the same sponsor.

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Data sources for this page

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