- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00172211
Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
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.
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- Taiwan Universithy Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The oxidative markers in month 3, 6, and 7
|
The insulin resistance in month 3, 6, and 7
|
Secondary Outcome Measures
Outcome Measure |
---|
The hematologic, biochemical markers, and peritoneal function
|
in month 3,6, and 7
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kwan-Dun Wu, Ph.D. & M.D., Section of Nephrology, Department of Internal Medicine, National Taiwan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 185-CL4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Failure,Chronic
-
Centre Hospitalier Universitaire DijonTerminatedEnd-stage Chronic Kidney FailureFrance
-
Baxter Healthcare CorporationRecruitingAcute Kidney Failure | Chronic Kidney FailureChina
-
Angiodynamics, Inc.TerminatedChronic Kidney Disease | Acute Kidney Injury | Acute Renal Failure | Renal Failure Chronic Contrast InducedUnited States
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
University of WashingtonJohns Hopkins University; National Institute of Diabetes and Digestive and... and other collaboratorsRecruitingChronic Kidney Diseases | Acute Renal Failure | Acute Renal Injury | Acute Kidney Failure | Chronic Renal Insufficiency | Kidney Failure, Acute | Renal Insufficiency, Acute | Acute Renal Insufficiency | Acute Kidney Insufficiency | Renal Failure, Acute | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney... and other conditionsUnited States
-
Hopital Jean MinjozUnknownCardiac Surgical Procedures | Preoperative KIDNEY FAILURE, CHRONIC | Postoperative KIDNEY FAILURE, ACUTEFrance
-
Nantes University HospitalNot yet recruiting
-
Ozge AKBABAAtaturk UniversityCompletedChronic Kidney FailureTurkey
-
Chinese PLA General HospitalCompletedKidney Failure,ChronicChina
-
Fatma Alzahraa Mohamed Ibrahim Hassan HaggagUnknown
Clinical Trials on Physioneal
-
University of Erlangen-Nürnberg Medical SchoolTerminated
-
Baxter Healthcare CorporationCompletedDiabetes | ESRD | CAPD | APDTaiwan, Korea, Republic of, Singapore, Hong Kong, Russian Federation
-
Baxter Healthcare CorporationCompletedDiabetes | ESRDAustralia, Canada, New Zealand
-
University of AarhusTerminated
-
Iperboreal Pharma SrlRecruitingEnd Stage Renal DiseaseDenmark, Sweden, Italy, Spain, United Kingdom, Germany