Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Effect of Glucose Degradation Products (GDP) on Endothelial Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01315314
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : March 17, 2011
Ministry of Health & Welfare, Korea
Fresenius Medical Care Korea
Information provided by:
Kyungpook National University Hospital

Brief Summary:
The purpose of this study is to evaluate the effects of neutral pH and low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation and endothelial dysfunction markers in incident PD patients.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Disorders Associated With Peritoneal Dialysis Drug: Balance, Fresenius Medical Care, Germany Phase 4

Detailed Description:

New peritoneal dialysis fluids (PDF) with neutral pH and low glucose degradation products (GDPs) are used in patients on peritoneal dialysis (PD). Low GDP fluids are reported to be more biocompatible than conventional PDF. Determination of biocompatibility has mainly focused on local peritoneal effects; recently, there has been interest in evaluating the systemic biocompatibility of these fluids.

In recent analyses of two retrospective cohorts of Korean PD patients, significant survival advantage was shown for patients treated with the biocompatible PDF compared to patients treated with conventional PDF. However, the mechanisms of survival advantage with low GPD PDF in these observational studies are difficult to assess. Additionally, it is not clear that new PDFs favorably impact risk markers of cardiovascular disease (CVD).

Epidemiologic studies identified an independent association between inflammation and risk of cardiovascular events and mortality; this association has been confirmed in patients with advanced chronic kidney diseases (CKD).Other evidence showed that clinically overt vascular events are preceded by endothelial dysfunction and increases in circulating markers of endothelial activation, including vascular cellular adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1.Moreover, there is an association between inflammation and elevated levels of soluble VCAM-1 and ICAM-1 in patients with or at risk of atherosclerosis. Elevated levels of soluble adhesion molecules are found in ESRD patients, especially in patients with CVD and malnutrition.

The investigators hypothesized that conventional PDF as well as uremia itself lead to local peritoneal changes such as peritoneal neoangiogenesis and fibrosis, effects related to ultrafiltration failure and subsequently volume overload. In addition, direct effect of GDPs and/or increased systemic levels of AGEs activate endothelial cells and increase levels of vascular adhesion molecules and inflammation. Both local and systemic effects of PDF are possibly associated with increased cardiovascular risks and mortality in PD patients.

This study aims to examine the effects of neutral pH and low GDP-containing PDF on systemic inflammation and endothelial dysfunction in incident PD patients in a randomized, controlled study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Neutral pH and Low Glucose Degradation Product-containing Peritoneal Dialysis Fluid on Systemic Markers of Inflammation and Endothelial Dysfunction: a Randomized, Controlled 1-year Follow-up Study
Study Start Date : October 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
No Intervention: conventional PDF (Stay safe)
Active Comparator: low GDP PDF (Balance) Drug: Balance, Fresenius Medical Care, Germany
low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF)
Other Name: Balance, Fresenius Medical Care

Primary Outcome Measures :
  1. Inflammation-endothelial-dysfunction index (IEDI) [ Time Frame: Baseline and 12 months ]
    Inflammation-endothelial-dysfunction index (IEDI) is a composite score derived from measurement of serum levels of CRP (high sensitivity assay), soluble VCAM-1 and soluble ICAM-1. Changes between the groups will be tested by analysis of covariance (ANCOVA) with baseline values as covariates. Serial data will also be analyzed using a linear mixed model.

Secondary Outcome Measures :
  1. Individual component markers of IEDI [ Time Frame: Baseline and 12 months ]
    individual component markers of the IEDI including sICAM-1, sVCAM-1, and hs-CRP

  2. RRF [ Time Frame: Baseline and 12 months ]
    residual renal function (RRF) as average of urea and creatinine clearances by 24 hour urine collection

  3. peritoneal clearance [ Time Frame: Baseline and 12 months ]
    peritoneal clearance as weekly Kt/V urea and creatinine clearance

  4. peritoneal ultrafiltration [ Time Frame: Baseline and 12 months ]
    peritoneal ultrafiltration volume

  5. peritoneal transport status [ Time Frame: Baseline and 12 months ]
    dialysate-to-plasma ratio of creatinine at 4 hours of peritoneal equilibration test

  6. serum albumin [ Time Frame: Baseline and 12 months ]
  7. LBM [ Time Frame: Baseline and 12 months ]
    lean body mass (LBM) estimated from creatinine kinetics

  8. nPNA [ Time Frame: Baseline and 12 months ]
    normalized protein equivalent of nitrogen appearance (nPNA)

  9. SGA [ Time Frame: Baseline and 12 months ]
    subjective global assessment (SGA) with a four item and seven-point scale

  10. Blood pressure [ Time Frame: Baseline and 12 months ]
    systolic and diastolic blood pressure

  11. use of antihypertensive medications [ Time Frame: Baseline and 12 months ]
    number of antihypertensive medications

  12. peritonitis rates [ Time Frame: 12 months ]
    peritonitis rates

  13. technique survival [ Time Frame: 12months ]
    technique survival by Kaplan-Meier survival analysis with Log-Rank test.

  14. patient survival [ Time Frame: 12 months ]
    patient survival by Kaplan-Meier survival analysis with Log-Rank test.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female patients aged over 18 years and less than 75 years
  • Within 90 days of initiation of first renal replacement treatment for ESRD
  • Selected for maintenance management by CAPD
  • Having provided informed consent
  • Physically and mentally capable of performing the therapy

Exclusion Criteria:

  • Patients were excluded if deemed to have less than 80% likelihood of survival for at least 1 year
  • episodes of peritonitis within prior 30 days
  • any malignancy other than treated skin carcinoma
  • uncontrolled congestive heart failure
  • recent (within 60 days) myocardial infarction or cerebrovascular accident
  • active systemic vasculitic disease including systemic lupus erythematosus, polyarteritis nodosa, ANCA-nephritis, active rheumatoid disease, or active venous thrombotic-embolic disease
  • any acute infection at the time of enrollment
  • active or actively treated tuberculosis
  • recent (within 30 days) systemic bacterial infection.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01315314

Layout table for location information
Korea, Republic of
Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University Hospital
Ministry of Health & Welfare, Korea
Fresenius Medical Care Korea
Layout table for investigator information
Study Chair: Yong-Lim Kim, Professor Kyungpook National University Hospital

Layout table for additonal information
Responsible Party: Yong-Lim, Kim, Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital Identifier: NCT01315314    
Other Study ID Numbers: IEDI MCS
A084001 ( Other Grant/Funding Number: Ministry for Health and Welfare, Republic of Korea (A084001) )
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: April 2007
Keywords provided by Kyungpook National University Hospital:
Glucose degradation products
Endothelial dysfunction
Soluble adhesion molecules
Peritoneal dialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dialysis Solutions
Pharmaceutical Solutions