Diurnal Variation of Mineral Metabolism and Protein Fermentation Metabolites in Peritoneal Dialysis Patients and Healthy Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01093456
First received: March 23, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition
Peritoneal Dialysis

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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum, urine and dialysate


Estimated Enrollment: 10
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Peritoneal dialysis
patients on peritoneal dialysis
Healthy volunteers

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093456

Contacts
Contact: Pieter Evenepoel, MD, PhD 003216344580 pieter.evenepoel@uz.kuleuven.ac.be

Locations
Belgium
University Hospital Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Pieter Evenepoel, MD, PhD    003216344580    pieter.evenepoel@uz.kuleuven.ac.be   
Principal Investigator: Pieter Evenepoel, MD,PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

Additional Information:
No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01093456     History of Changes
Other Study ID Numbers: ML6275
Study First Received: March 23, 2010
Last Updated: December 17, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
diurnal variation in parameters of mineral metabolism and protein fermentation metabolism

ClinicalTrials.gov processed this record on October 20, 2014