Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Patients affected by end-stage renal disease (ESRD) are subjected to enhanced oxidative
stress, as a result of reduced anti-oxidant systems and increased pro-oxidant activity.
Besides, insulin resistance is also very common in ESRD patients. Both enhanced oxidative
stress and insulin resistance increase the risk of atherosclerosis and cardiovascular
mortality, and intention to reduce oxidative stress and insulin resistance is important in
ESRD patients who suffer from high cardiovascular risk.
The high concentration of glucose and glucose degradation products (GDP), high lactate, and
low pH in conventional peritoneal dialysis (PD) solutions are known as bioincompatible
factors, which are believed to increase oxidative stress in PD patients. Physioneal®, a more
biocompatible dialysis solution with neutral pH, physiologic bicarbonate concentration and
low GDP level, has been applied in Europe for several years. Previous studies of Physioneal®
have revealed advantages of improved infusion pain, more efficient acid-base control,
increased ultrafiltration, and reduced peritonitis duration. However, its effects on
oxidative stress and insulin resistance in peritoneal dialysis patients are not reported yet.
The comparison of oxidative stress and insulin resistance before and after using Physioneal®
may help to elucidate the possibly beneficial effects on uremic patients, which frequently
suffer from increased oxidative stress and insulin resistance.
Thirty continuous ambulatory peritoneal dialysis (CAPD) patients will be selected in this
study, and receive conventional solution (Dianeal® PD-2 or PD-4) for a baseline period of 3
months. Then Physioneal® will be used for 3 months. Clinical conditions, biochemical and
hematological parameters, oxidative markers in blood and effluent, and insulin resistance
will be measured at baseline, before and after Physioneal®, and some markers will be measured
1 month after discontinuing Physioneal® and changing back to conventional solution. The
medication used in each patient will be recorded, and the dialysis prescription will be
adjusted by a nephrologist according to clinical data. The data collected before and after
Physioneal® will be analyzed by paired-t test.