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Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2) (CITRUGRELE 2)

This study is not yet open for participant recruitment.
Verified May 2012 by Nantes University Hospital
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01386034
First received: June 24, 2011
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.


Condition Intervention Phase
Intestinal Failure
 Drug: Citrulline and placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure : a Prospective, Randomized, Double-blind, Cross-over Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • whole body protein synthesis [ Designated as safety issue: No ]
    To determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal insufficiency, as measured using an intravenous infusion of stable isotope labelled leucine.


Secondary Outcome Measures:
  • nitrogen balance [ Designated as safety issue: No ]
    Using a 6-h urine collection, to determine the effect of oral citrulline administration on nitrogen balance

  • Measure of insulin [ Designated as safety issue: No ]
    to determine whether the putative protein anabolic effect of citrulline is mediated by insulin or insulin-like-growth factor 1 (IGF-1), based on measurement of their plasma concentrations

  • Measure of insulin-like-growth factor 1 (IGF-1) [ Designated as safety issue: No ]
    To determine whether the putative protein anabolic effect of citrulline is mediated by insulin or insulin-like-growth factor 1 (IGF-1), based on measurement of their plasma concentrations.


Estimated Enrollment: 12
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citrulline/Placebo Drug: Citrulline and placebo
After receiving a 7-day oral supplementation with either citrulline or placebo, each subject will be admitted for a half day, after an overnight fast, and will receive a 5-h intravenous infusion of L-[1-13C]leucine. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, using gas chromatography-mass spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. Then the subject take no treatment for 13 days. The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with either citrulline or placebo.
Experimental: Placebo/Citrulline Drug: Citrulline and placebo
After receiving a 7-day oral supplementation with either citrulline or placebo, each subject will be admitted for a half day, after an overnight fast, and will receive a 5-h intravenous infusion of L-[1-13C]leucine. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, using gas chromatography-mass spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. Then the subject take no treatment for 13 days. The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with either citrulline or placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult between 18 and 75 years
  • Patient with short bowel syndrome
  • Patient with an incompetent small intestine after intestinal resection
  • Patient fed orally and beyond more than 6 weeks after surgery
  • Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
  • No current artificial feeding (parenteral)
  • No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency
  • No chronic inflammatory disease (intestinal or other)
  • No current corticosteroid treatment
  • Fasting blood glucose below 6mmol/L
  • Patient able to understand benefits and risks of protocol
  • Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study
  • Signed informed consent

Exclusion Criteria:

  • Subject not fulfilling inclusion criteria
  • Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386034

Contacts
Contact: Dominique DARMAUN, Pr +33 2 40 08 42 75 dominique.darmaun@chu-nantes.fr

Locations
France
Nantes University Hospital Not yet recruiting
Nantes, France
Contact: Dominique DARMAUN, Pr     +33 2 40 08 42 75     dominique.darmaun@chu-nantes.fr    
Principal Investigator: Dominique DARMAUN, Pr            
Clinique Saint Yves Not yet recruiting
Rennes, France
Contact: Denis PICOT, Dr     +33 2 99 26 26 00     picot@clinique-styves.fr    
Principal Investigator: Denis PICOT, Dr            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Dominique DARMAUN, Pr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Anne OMNES, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01386034     History of Changes
Other Study ID Numbers: 09/5-W
Study First Received: June 24, 2011
Last Updated: May 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Nutrition, protein metabolism, stable isotopes, mass spectrometry, intestinal failure

ClinicalTrials.gov processed this record on June 18, 2013