Abstract
Background: New-onset diabetes is common after kidney transplantation but the benefit of lifestyle intervention to improve glucose metabolism post transplantation is unproven.
Methods: We conducted a single-center, randomised controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3-24 months post transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behaviour change techniques) versus passive intervention (leaflet advice alone). Primary outcome was six-month change in insulin secretion, insulin sensitivity and disposition index. Secondary outcomes included patient-reported outcomes, cardio-metabolic parameters, clinical outcomes and safety endpoints.
Results: Between August 17th 2015 and December 18th 2017, 130 individuals were recruited of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446 [95% CI -3184 to 2292], p=0.748), insulin sensitivity (mean difference -0.45 [95% CI -1.34 to 0.44], p=0.319) or disposition index (mean difference -940 [95% CI -5655 to 3775], p=0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of post transplantation diabetes (7.6% versus 15.6% respectively, p=0.123), reduction in fat mass (mean difference -1.537kg [-2.947 to -0.127], p=0.033) and improvement in weight (mean difference -2.47kg [-4.01 to -0.92], p=0.002). No serious adverse events were noted.
Conclusions: Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.
Trial Registration: Registered with clinicaltrials.org registry (identifier; NCT02233491).
Methods: We conducted a single-center, randomised controlled trial involving 130 nondiabetic kidney transplant recipients with stable function between 3-24 months post transplantation. Participants were randomly assigned in a 1:1 ratio to receive active intervention (lifestyle advice delivered by renal dietitians using behaviour change techniques) versus passive intervention (leaflet advice alone). Primary outcome was six-month change in insulin secretion, insulin sensitivity and disposition index. Secondary outcomes included patient-reported outcomes, cardio-metabolic parameters, clinical outcomes and safety endpoints.
Results: Between August 17th 2015 and December 18th 2017, 130 individuals were recruited of whom 103 completed the study (drop-out rate 20.8%). Active versus passive intervention was not associated with any change in glucose metabolism; insulin secretion (mean difference -446 [95% CI -3184 to 2292], p=0.748), insulin sensitivity (mean difference -0.45 [95% CI -1.34 to 0.44], p=0.319) or disposition index (mean difference -940 [95% CI -5655 to 3775], p=0.693). Clinically, active versus passive lifestyle intervention resulted in reduced incidence of post transplantation diabetes (7.6% versus 15.6% respectively, p=0.123), reduction in fat mass (mean difference -1.537kg [-2.947 to -0.127], p=0.033) and improvement in weight (mean difference -2.47kg [-4.01 to -0.92], p=0.002). No serious adverse events were noted.
Conclusions: Active lifestyle intervention led by renal dietitians did not improve surrogate markers of glucose metabolism. Further investigation is warranted to determine if clinical outcomes can be improved using this methodology.
Trial Registration: Registered with clinicaltrials.org registry (identifier; NCT02233491).
| Original language | English |
|---|---|
| Pages (from-to) | 1491-1499 |
| Journal | Transplantation |
| Volume | 104 |
| Issue number | 7 |
| Early online date | 18 Sept 2019 |
| DOIs | |
| Publication status | Published - 1 Jul 2020 |
