Randomized, controlled trial of glucose-sparing peritoneal dialysis in diabetic patients

J Am Soc Nephrol. 2013 Nov;24(11):1889-900. doi: 10.1681/ASN.2012100987. Epub 2013 Aug 15.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Diabetic Nephropathies / blood
  • Diabetic Nephropathies / therapy*
  • Female
  • Glucose / administration & dosage*
  • Glycated Hemoglobin / analysis
  • Humans
  • Lipids / blood
  • Male
  • Middle Aged
  • Peritoneal Dialysis / adverse effects
  • Peritoneal Dialysis / methods*

Substances

  • Glycated Hemoglobin A
  • Lipids
  • hemoglobin A1c protein, human
  • Glucose