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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172211
First received: September 12, 2005
Last updated: May 4, 2008
Last verified: January 2007
  Purpose

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.


Condition Intervention
Kidney Failure,Chronic
Drug: Physioneal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The oxidative markers in month 3, 6, and 7
  • The insulin resistance in month 3, 6, and 7

Secondary Outcome Measures:
  • The hematologic, biochemical markers, and peritoneal function
  • in month 3,6, and 7

Estimated Enrollment: 30
Study Start Date: September 2005
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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, and/or 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, i.e., 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Older than 18 years old, younger than 70 years old
  2. Non-diabetic ESRD patients, e.g. chronic glomerulonephritis, hypertensive nephrosclerosis, interstitial nephritis, polycystic kidney disease, etc.
  3. Undergoing CAPD for at least 3 months and less than 60 months
  4. Kt/Vurea (normalized by Watson's method) is greater than 1.7, and serum albumin is greater than 3.5 g/dL

Exclusion Criteria:

  1. Unstable clinical conditions or evidence of malignancy
  2. Diabetes mellitus
  3. Pregnancy
  4. Have peritonitis in recent 3 months or other active bacterial infections
  5. Taking any medication known to markedly interfere oxidative stress, e.g. large dose of vitamin C (greater than 500 mg/day) or vitamin E (greater than 400 IU/day).
  6. Medical history of systemic lupus erythematosus or rheumatoid arthritis
  7. Serum potassium is less than 3.0 mEq/l
  8. Participate in another study that would interfere with the outcome of this study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00172211

Locations
Taiwan
Taiwan Universithy Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: Kwan-Dun Wu, Ph.D. & M.D. Section of Nephrology, Department of Internal Medicine, National Taiwan University
  More Information

No publications provided

Responsible Party: Shao-Yu Yang, Attending Physician, Nation Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00172211     History of Changes
Other Study ID Numbers: 185-CL4
Study First Received: September 12, 2005
Last Updated: May 4, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Physioneal
Peritoneal dialysis
Oxidative stress
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Kidney Failure, Chronic
Renal Insufficiency
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014