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NCT04119765 Clinical Trial

Plasma Oxalate in Patient With Short Bowel

Short Bowel Syndrome Clinical Trial

— OXAGO  

Official title:
Plasma Oxalate in Patient With Short Bowel

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04119765
Other study ID # 69HCL18_0408
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 27, 2020
Est. completion date May 4, 2022

Study information
Verified date July 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date May 4, 2022
Est. primary completion date May 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Type II short bowel for more than 6 months - Affiliated to a social health care Exclusion Criteria: - Primary hyperoxaluria - Other type of short bowel than type II - Minor patient or major patient protected by the law

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Blood sampling
blood sampling will be used to perform oxalemia and FGF23 quantitative analysis
• Urine sampling
urine sampling will be used to measure glycolate urinary rate (glycolaturia) and to perform urinary inflammation markers quantitative analysis
Procedure:
• Pulse Wave Velocity (PWV) measurement
PWV will be measured thank to the Complior® device
• central pressure measurement
central pressure will be measured thank to the Complior® device

Locations
Country Name City State
France Nephrology Department, Edouard Herriot Hospital Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma oxalate rate (oxalemia) this sample measures the plasma oxalate rate at inclusion
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