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Completed

NCT Number: NCT01093456

Diurnal Variation of Uremic Solutes in Peritoneal Dialysis

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,..)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 25, 2010
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.