RESUMO
Half of kidney transplant recipients (KTRs) gain more than 5% of their body weight in the first year following transplantation. KTRs have requested support with physical activity (PA) and weight gain prevention, but there is no routine care offered. There are few high-quality studies investigating the clinical value of diet, PA or combined interventions to prevent weight gain. The development and evaluation of theoretically informed complex-interventions to mitigate weight gain are warranted. The aims of this mixed-methods randomized controlled trial (RCT) were to explore the feasibility, acceptability and user-experience of a digital healthcare intervention (DHI) designed to prevent post-transplant weight gain, in preparation for a large multi-center trial. New KTRs (<3 months) with access to an internet compatible device were recruited from a London transplant center. The usual care (UC) group received standard dietary and PA advice. The intervention group (IG) received access to a 12-week DHI designed to prevent post-transplant weight gain. Primary feasibility outcomes included screening, recruitment, retention, adherence, safety and hospitalizations and engagement and experience with the DHI. Secondary outcomes (anthropometrics, bioimpedance, arterial stiffness, 6-minute walk distance and questionnaires) were measured at baseline, 3- and 12-months. 38 KTRs were screened, of which 32 (84.2%) were eligible, and of those 20 (62.5%) consented, with 17 participants (85%) completing baseline assessment (Median 49 years, 58.8% male, Median 62 days post-transplant). Participants were randomized using a computer-generated list (n = 9 IG, n = 8 UC). Retention at 12-months was 13 (76.4%) (n = 6 IG, n = 7 UC). All a priori progression criteria were achieved. There were no associated adverse events. Reflexive thematic analysis revealed four themes regarding trial participation and experience whilst using the DHI. Halting recruitment due to COVID-19 resulted in the recruitment of 40% of the target sample size. Mixed-methods data provided important insights for future trial design. A definitive RCT is warranted and welcomed by KTRs. Clinical Trial Registration: www.clinicalTrials.gov, identifier: NCT03996551.
RESUMO
BACKGROUND: Diabetes and malnutrition are common in patients with kidney failure. We aimed to evaluate the postprandial glucose response to oral nutritional supplement drinks (ONSs) in patients with diabetes undergoing hemodialysis treatment. METHODS: A randomized, single-blind crossover study was conducted in patients with diabetes, and requiring chronic hemodialysis. Patients consumed either a renal-specific ONS, macronutrient-matched ONS, or standard ONS on 3 separate study days, during dialysis, following an overnight fast. Blood was collected before and 15, 30, 45, 60, 90, 120, and 180 minutes post ingestion. Mean net incremental area under the curve (iAUC) and peak incremental blood glucose concentration were compared across conditions, using analyses of variance. RESULTS: Consumption of the renal-specific ONS resulted in the lowest mean net iAUC (87.9 ± 169.0 mmol/L per 3 hours) compared with macronutrient-matched (188.0 ± 127.5 mmol/L per 3 hours) and standard ONS (199.5 ± 169.2 mmol/L per 3 hours) (F2,30 = 5.115, P = 0.012, partial n2 = 0.254). Pairwise comparisons demonstrated a mean difference of 100.1 mmol/L per 3 hours (95% CI, -2.8 to 202.9) in mean iAUC between the renal-specific ONS and macronutrient-matched ONS (P = 0.058). Peak blood glucose concentration, corrected for baseline, was significantly lower after the renal-specific ONS (1.40 ± 1.0 mmol/L) compared with both macronutrient-matched (2.02 ± 0.71 mmol/L, P = 0.036) and standard ONS (2.3 ± 1.06 mmol/L, P = 0.017). CONCLUSION: A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient-matched ONS or standard ONS in patients with diabetes during hemodialysis.