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Genetic Testing and Counseling to Reduce Diabetic Complications

6 marzo 2022 aggiornato da: Professor Ronald C.W. Ma, Chinese University of Hong Kong

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

435

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Shatin, Hong Kong
        • Prince of Wales Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Personalized risk counselling
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
Motivational message- towards lifestyle change, improved compliance and risk factors control Review overall control of clinical risk factors based on lab test results
Comparatore placebo: Normal usual care
Intervention includes normal usual care. General education on diabetes and diabetic complications
General education on diabetes and diabetic complications

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: At 1 year
primary outcome of 3 out of 5 targets achieved as defined above
At 1 year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
microalbuminuria as a marker of degree of renal damage
Lasso di tempo: At 1 year
new onset of microalbuminuria at 1 year follow-up
At 1 year
Patient empowerment as measured on the Chinese Diabetes Empowerment Scale (DES)
Lasso di tempo: At 1 year
Score on the DES
At 1 year
Patient behavior measured on the Summary of Diabetes Self-care Activities (SDSCA)
Lasso di tempo: At 1 year
Score of diabetes self-care as measured by the SDSCA
At 1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Ronald C Ma, MB BChir, Chinese University of Hong Kong

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 febbraio 2015

Completamento primario (Effettivo)

18 aprile 2017

Completamento dello studio (Effettivo)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

10 febbraio 2015

Primo inviato che soddisfa i criteri di controllo qualità

17 febbraio 2015

Primo Inserito (Stima)

18 febbraio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • GEM Study

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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