Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172211
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2005-09-12
Brief Title:
Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 Enhanced oxidative stress in uremic patients increases the risk of atherosclerosis and cardiovascular mortality Furthermore bioincompatibility of dialysis therapy further increases oxidative stress High concentration of glucose high lactate low pH andor high concentration of glucose degradation products GDP are known as bioincompatible factors and believed to increase oxidative stress in peritoneal dialysis patients A more biocompatible dialysis solution ie neutral pH containing physiologic concentration of bicarbonate and low concentration of GDP has been developed There is a growing body of in vitro studies showing this neutral bicarbonate containing dialysis solution more biocompatible compared to conventional solutions However its effects on oxidative stress in peritoneal dialysis patients are not reported yet On the other hand insulin resistance is associated with cardiovascular disease and it is very common in uremic patients Some animal studies suggested that reduced oxidative stress enhanced insulin sensitivity and the effects of reduced oxidative stress in human have not been extensively investigated Previous studies of Physioneal a kind of more biocompatible dialysis solution which contains bicarbonate have revealed advantages of improved infusion pain more efficient acid-base control increased ultrafiltration and reduced peritonitis duration 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None