Kidney Failure,ChronicNCT00172211
Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
A study testing Physioneal in people with Kidney Failure,Chronic, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Failure,Chronic
- What is being tested?
- Physioneal
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Kidney Failure,Chronic
- Being tested
- Physioneal
- Keywords
- Physioneal, Peritoneal dialysis, Oxidative stress, insulin resistance
- Medical subject headings
- Kidney Failure, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysionealDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The oxidative markers in month 3, 6, and 7
The insulin resistance in month 3, 6, and 7
Secondary outcomes (2)
The hematologic, biochemical markers, and peritoneal function
in month 3,6, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure,ChronicStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Investigators
- Kwan-Dun Wu, Ph.D. & M.D., Principal investigator, Section of Nephrology, Department of Internal Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172211
- Sponsor's protocol ID
- 185-CL4
- Status last verified
- Jan 2007
- First submitted
- 12 Sep 2005
- Last updated
- 7 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxidative Stress and Insulin Resistance Before and After Using Physioneal in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00172211
- Acronym / sponsor ID
- 185-CL4
- Conditions
- Kidney Failure,Chronic
- Keywords
- Physioneal, Peritoneal dialysis, Oxidative stress, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physioneal | Drug | – |
Primary outcome
The oxidative markers in month 3, 6, and 7
The insulin resistance in month 3, 6, and 7
2 secondary outcomes
The hematologic, biochemical markers, and peritoneal function
in month 3,6, and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwan-Dun Wu, Ph.D. & M.D. principal investigator
Section of Nephrology, Department of Internal Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physioneal in people with Kidney Failure,Chronic, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The oxidative markers in month 3, 6, and 7. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008.