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NCT01093456 Clinical Trial

Diurnal Variation of Uremic Solutes in Peritoneal Dialysis

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01093456
Other study ID # ML6275
Secondary ID
Status Completed
Phase N/A
First received March 23, 2010
Last updated May 12, 2016
Start date February 2010
Est. completion date December 2012

Study information
Verified date December 2013
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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,..)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium University Hospital Leuven Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the diurnal variation of serum concentrations of phosphate and protein fermentation metabolites in healthy volunteers as compared to dialysis patients. 4 months No
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