Transplant Trial Watch

Comparing glycaemic benefits of active versus passive lifestyle intervention in kidney allograft recipients (CAVIAR): a randomised controlled trial.

Kuningas, K., Driscoll, J. et al. (2019).

Transplantation [record in progress].


Aims
This study investigates the benefit of active versus passive lifestyle intervention after kidney transplantation in preventing abnormal glycaemic control.

Interventions
Kidney allograft recipients were randomly assigned to receive active intervention (lifestyle advice delivered by renal dietitians using behaviour change techniques) or a passive intervention (leaflet advice alone).

Participants
30 nondiabetic kidney transplant recipients with stable function between 3-24 months post transplantation.

Outcomes
Primary outcomes were assessed as the change in insulin secretion, insulin sensitivity and disposition index, 6 months post-transplantation. Secondary outcomes included patient-reported outcomes, cardio-metabolic parameters, clinical outcomes and safety endpoints.

Follow-up
6 months

CET Conclusions
This single-centre randomised controlled trial evaluated the benefit of active lifestyle intervention delivered by renal dieticians. The study was not blinded due to the nature of the intervention. The intervention did not improve any surrogate markers of glucose metabolism (insulin secretion, insulin sensitivity, disposition index). The study experienced 20% dropout, however it had been designed with an adequate power calculation to account for this degree of withdrawals.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
No

Trial registration
ClinicalTrial.org - NCT02233491

Funding source
Industry funded