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Effect of Glucose Degradation Products (GDP) on Endothelial Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315314
First Posted: March 15, 2011
Last Update Posted: March 17, 2011
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.
Collaborators:
Ministry of Health & Welfare, Korea
Fresenius Medical Care Korea
Information provided by:
Kyungpook National University
March 11, 2011
March 15, 2011
March 17, 2011
October 2005
April 2008   (Final data collection date for primary outcome measure)
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.
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 and soluble ICAM. 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. Survival analysis will be done by Kaplan-Meier survival analysis with Log-Rank test.
Complete list of historical versions of study NCT01315314 on ClinicalTrials.gov Archive Site
  • 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
  • RRF [ Time Frame: Baseline and 12 months ]
    residual renal function (RRF) as average of urea and creatinine clearances by 24 hour urine collection
  • peritoneal clearance [ Time Frame: Baseline and 12 months ]
    peritoneal clearance as weekly Kt/V urea and creatinine clearance
  • peritoneal ultrafiltration [ Time Frame: Baseline and 12 months ]
    peritoneal ultrafiltration volume
  • peritoneal transport status [ Time Frame: Baseline and 12 months ]
    dialysate-to-plasma ratio of creatinine at 4 hours of peritoneal equilibration test
  • serum albumin [ Time Frame: Baseline and 12 months ]
  • LBM [ Time Frame: Baseline and 12 months ]
    lean body mass (LBM) estimated from creatinine kinetics
  • nPNA [ Time Frame: Baseline and 12 months ]
    normalized protein equivalent of nitrogen appearance (nPNA)
  • SGA [ Time Frame: Baseline and 12 months ]
    subjective global assessment (SGA) with a four item and seven-point scale
  • Blood pressure [ Time Frame: Baseline and 12 months ]
    systolic and diastolic blood pressure
  • use of antihypertensive medications [ Time Frame: Baseline and 12 months ]
    number of antihypertensive medications
  • peritonitis rates [ Time Frame: 12 months ]
    peritonitis rates
  • technique survival [ Time Frame: 12months ]
    technique survival by Kaplan-Meier survival analysis with Log-Rank test.
  • patient survival [ Time Frame: 12 months ]
    patient survival by Kaplan-Meier survival analysis with Log-Rank test.
Individual component markers of IEDI, RRF, LBM, nPCR and SGA [ Time Frame: Baseline and 12 months ]
Secondary outcome variables are the individual component markers of the IEDI including sICAM-1, sVCAM-1, and hs-CRP, residual renal function (RRF) as average of urea and creatinine clearances, peritoneal clearance as weekly Kt/V urea and creatinine clearance, peritoneal ultrafiltration, and peritoneal transport status by PET. In addition, nutritional indices including serum albumin, lean body mass (LBM), normalized protein equivalent of nitrogen appearance (nPNA), and subjective global assessment (SGA) will be evaluated.
Not Provided
Not Provided
 
Effect of Glucose Degradation Products (GDP) on Endothelial Dysfunction
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Failure, Chronic
  • Disorders Associated With Peritoneal Dialysis
Drug: Balance, Fresenius Medical Care, Germany
low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF)
Other Name: Balance, Fresenius Medical Care
  • No Intervention: conventional PDF (Stay safe)
  • Active Comparator: low GDP PDF (Balance)
    Intervention: Drug: Balance, Fresenius Medical Care, Germany
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
April 2008
April 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01315314
IEDI MCS
A084001 ( Other Grant/Funding Number: Ministry for Health and Welfare, Republic of Korea (A084001) )
No
Not Provided
Not Provided
Yong-Lim, Kim, Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital
Kyungpook National University
  • Ministry of Health & Welfare, Korea
  • Fresenius Medical Care Korea
Study Chair: Yong-Lim Kim, Professor Kyungpook National University
Kyungpook National University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP