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Diurnal Variation of Uremic Solutes in Peritoneal Dialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093456
First Posted: March 25, 2010
Last Update Posted: May 13, 2016
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.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  Purpose
Study on the daytime variation of uremic retention solutes and markers of bone-mineral metabolism in patients with end-stage kidney disease treated with peritoneal dialysis

Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Diurnal Variation of Mineral Metabolism and Protein Fermentation Metabolites in Peritoneal Dialysis Patients and Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • To evaluate the diurnal variation of serum concentrations of phosphate and protein fermentation metabolites in healthy volunteers as compared to dialysis patients. [ Time Frame: 4 months ]

Biospecimen Retention:   Samples Without DNA
whole blood, serum, urine and dialysate

Enrollment: 18
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic kidney disease
ESKD patients treated with peritoneal dialysis
Healthy volunteers
healthy volunteers, aged 18 years and above

Detailed Description:

Many epidemiological studies have pointed to the association between serum parameters of phosphate metabolism (phosphate, FGF23) and microbiotic protein fermentation (p-cresyl sulphate [PCS], indoxyl sulphate [IS]) on the one hand and increased risk of all-cause and cardiovascular death on the other hand.

Hypothesis: Due to failing feed-back mechanisms, diurnal variation of serum concentrations of serum phosphate and fermentation metabolites will be more pronounced in dialysis patients, especially in those with negligible residual kidney function.

Clinical studies assessing this issue are scarce to non-existing.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Peritoneal dialysis patients Healthy volunteers
Criteria

Inclusion Criteria:

  • Age 18-55
  • Normal dietary habits

Exclusion Criteria:

  • Treatment with systemic antibiotics within one month Major abdominal surgery Drugs known to affect gastrointestinal physiology (acid secretion inhibitors, prokinetics, laxatives, probiotics, prebiotics,..)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01093456


Locations
Belgium
University Hospital
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Pieter Evenepoel, MD, PhD UZ Leuven
  More Information

Additional Information:
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01093456     History of Changes
Other Study ID Numbers: ML6275
First Submitted: March 23, 2010
First Posted: March 25, 2010
Last Update Posted: May 13, 2016
Last Verified: December 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
diurnal variation
peritoneal dialysis
uremic retention solutes
phosphorous
indoxyl sulfate
p-cresol sulfate

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency