Randomized, Controlled Trial of Glucose-Sparing Peritoneal Dialysis in Diabetic Patients

Abstract

Glucose-containing peritoneal dialysis solutions may exacerbate metabolic abnormalities and increase cardiovascular risk in diabetic patients. Here, we examined whether a low-glucose regimen improves metabolic control in diabetic patients undergoing peritoneal dialysis. Eligible patients were randomly assigned in a 1:1 manner to the control group (dextrose solutions only) or to the low-glucose intervention group (IMPENDIA trial: combination of dextrose-based solution, icodextrin and amino acids; EDEN trial: a different dextrose-based solution, icodextrin and amino acids) and followed for 6 months. Combining both studies, 251 patients were allocated to control (n=127) or intervention (n=124) across 11 countries. The primary endpoint was change in glycated hemoglobin from baseline. Mean glycated hemoglobin at baseline was similar in both groups. In the intention-to-treat population, the mean glycated hemoglobin profile improved in the intervention group but remained unchanged in the control group (0.5% difference between groups; 95% confidence interval, 0.1% to 0.8%; P=0.006). Serum triglyceride, very-low-density lipoprotein, and apolipoprotein B levels also improved in the intervention group. Deaths and serious adverse events, including several related to extracellular fluid volume expansion, increased in the intervention group, however. These data suggest that a low-glucose dialysis regimen improves metabolic indices in diabetic patients receiving peritoneal dialysis but may be associated with an increased risk of extracellular fluid volume expansion. Thus, use of glucose-sparing regimens in peritoneal dialysis patients should be accompanied by close monitoring of fluid volume status.

Longitudinal Trend in Lipid Profile of Incident Peritoneal Dialysis Patients is Not Influenced by the Use of Biocompatible Solutions

“…TG, HDL, TC/HDL, and VLDL), and appeared to completely account for the effect of PD duration on HDL and TC/HDL levels. These results are in keeping with the general consensus in that hyperlipidemia seen in PD patients largely relates to continuous absorption of glucose from PD solutions used (25 (8)(9)(10)(11). Although Li and Fengxian concluded in their study a lack of association between glucose concentration in the PD solution and lipid profile in CAPD patients, the 24-h glucose loading from PD solutions was positively correlated with TG (r = 0.159, p < 0.05) and negatively associated with HDL levels (r = -0.166, p < 0.05) (26).…”

A Patient on Peritoneal Dialysis with Refractory Volume Overload

“…Systematic review confirms improved volume management without a deleterious effect on RRF (18). A randomized, controlled study using icodextrin as part of a glucose-sparing regimen in patients with diabetes showed improved plasma glucose and lipid control, although there was a signal relating to increased volume overload-related adverse events (19). Clearly, although it is important not to overuse dialysate glucose concentrations, it is essential that sufficient UF is achieved to maintain euvolemia.…”

Glükózterhelés a peritonealis dialízisben. Újabb elméleti megfontolások

“…Az IMPENDIA és EDEN tanulmányok a glükóztaka-rékos PD-rezsimek előnyét jelezték a HbA 1c és a lipidparaméterek (triglicerid, VLDL, apolipoprotein-B) vonatkozásában, de a volumentúlterheléssel jellemezhető adverz események és a halálozás nagyobb volt az intervenciós ágon [37]. Elméleti szinten megkérdőjelezhetet-len a glükózmentes PD-oldatok használatának szükség-szerűsége.…”