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Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients

NCT00172211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-05-07

No results posted yet for this study

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.

Conditions

  • Kidney Failure,Chronic

Interventions

DRUG

Physioneal

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Kwan-Dun Wu, Ph.D. & M.D. · Section of Nephrology, Department of Internal Medicine, National Taiwan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-09-30
Completion
2006-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00172211 on ClinicalTrials.gov