Randomized, controlled trial of glucose-sparing peritoneal dialysis in diabetic patients.
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.
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong;
Philip K T
PK
Li
Bruce F
BF
Culleton
Amaury
A
Ariza
Jun-Young
JY
Do
David W
DW
Johnson
Mauricio
M
Sanabria
Ty R
TR
Shockley
Ken
K
Story
Andrey
A
Vatazin
Mauro
M
Verrelli
Alex W
AW
Yu
Joanne M
JM
Bargman
D000328:Adult; D000368:Aged; D003928:Diabetic Nephropathies / Q000097:blood / Q000628:therapy*; D005260:Female; D005947:Glucose / Q000008:administration & dosage*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects / Q000379:methods*
D005947:Glucose; D006442:Glycated Hemoglobin; D008055:Lipids; C517652:hemoglobin A1c protein, human