Plasma Oxalate in Patient With Short Bowel

NCT04119765 | Completed

• 1 other identifier: 69HCL18_0408
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Short Bowel Syndrome; Hyperoxaluria; Hyperoxalemia

Outcome Measures

Primary Outcomes (1)

• Plasma oxalate rate (oxalemia)

  this sample measures the plasma oxalate rate

  at inclusion

Interventions

Blood sampling BIOLOGICAL

blood sampling will be used to perform oxalemia and FGF23 quantitative analysis

Urine sampling BIOLOGICAL

urine sampling will be used to measure glycolate urinary rate (glycolaturia) and to perform urinary inflammation markers quantitative analysis

Pulse Wave Velocity (PWV) measurement PROCEDURE

PWV will be measured thank to the Complior® device

central pressure measurement PROCEDURE

central pressure will be measured thank to the Complior® device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

type II short bowel patient

You may qualify if:

• Age ≥ 18 years
• Type II short bowel for more than 6 months
• Affiliated to a social health care

You may not qualify if:

• Primary hyperoxaluria
• Other type of short bowel than type II
• Minor patient or major patient protected by the law

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Nephrology Department, Edouard Herriot Hospital

Lyon, 69003, France

Location

MeSH Terms

Conditions

Short Bowel Syndrome; Hyperoxaluria

Interventions

Blood Specimen Collection; Weights and Measures

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sandrine Lemoine, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: February 27, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

FR (1)