Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
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ClinicalTrials.gov Identifier: NCT00172211 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: May 7, 2008
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Failure,Chronic | Drug: Physioneal | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | December 2006 |

- The oxidative markers in month 3, 6, and 7
- The insulin resistance in month 3, 6, and 7
- The hematologic, biochemical markers, and peritoneal function
- in month 3,6, and 7

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Older than 18 years old, younger than 70 years old
- Non-diabetic ESRD patients, e.g. chronic glomerulonephritis, hypertensive nephrosclerosis, interstitial nephritis, polycystic kidney disease, etc.
- Undergoing CAPD for at least 3 months and less than 60 months
- Kt/Vurea (normalized by Watson's method) is greater than 1.7, and serum albumin is greater than 3.5 g/dL
Exclusion Criteria:
- Unstable clinical conditions or evidence of malignancy
- Diabetes mellitus
- Pregnancy
- Have peritonitis in recent 3 months or other active bacterial infections
- 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).
- Medical history of systemic lupus erythematosus or rheumatoid arthritis
- Serum potassium is less than 3.0 mEq/l
- Participate in another study that would interfere with the outcome of this study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00172211
Taiwan | |
Taiwan Universithy Hospital | |
Taipei, Taiwan |
Principal Investigator: | Kwan-Dun Wu, Ph.D. & M.D. | Section of Nephrology, Department of Internal Medicine, National Taiwan University |
Responsible Party: | Shao-Yu Yang, Attending Physician, Nation Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00172211 History of Changes |
Other Study ID Numbers: |
185-CL4 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | May 7, 2008 |
Last Verified: | January 2007 |
Keywords provided by National Taiwan University Hospital:
Physioneal Peritoneal dialysis Oxidative stress insulin resistance |
Additional relevant MeSH terms:
Insulin Resistance Renal Insufficiency Kidney Failure, Chronic Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Insulin Hypoglycemic Agents Physiological Effects of Drugs |