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Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis (AMINOPOUCH)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Aarhus University Hospital
Sponsor:
Information provided by (Responsible Party):
Anders Mark Christensen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT02084550
First received: March 5, 2014
Last updated: March 10, 2014
Last verified: March 2014

March 5, 2014
March 10, 2014
June 2014
June 2015   (final data collection date for primary outcome measure)
  • Phenylalanine kinetics [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

    Phenylalanine balance is determined by:

    PheBal = (PheA - PheV) x F

    Where PheBal is the phenylalanine balance (mg/L), PheA is the arterial concentration of phenylalanine, PheV is the venous concentration of phenylalanine, and F is the blood flow.

  • Tyrosine kinetics [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

    Tyrosine balance is determined by:

    TyrBal = (TyrA - TyrV) x F

    Where TyrBal is the tyrosine balance, TyrA is the arterial concentration of tyrosine, TyrV is the venous concentration of tyrosine, and F is the blood flow.

  • Palmitate balance [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    Palmitate net balance will be estimated using blood flow and arterio-venous differenves in specific activity
Same as current
Complete list of historical versions of study NCT02084550 on ClinicalTrials.gov Archive Site
Plasma changes in hormones and energy sources [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Plasma changes in the levels of insulin, glucagon, catecholamines, cortisol, IGF[1], growth hormone, glycerol, urea, glucose
Same as current
Not Provided
Not Provided
 
Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis
Not Provided

The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical outcome is wellknown. This catabolism is especially pronounced in patients with acute or chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into both these categories.

To prevent this undesirable catabolism, we will investigate the effects of intravenous administration of predominantly anabolic amino acids (with an amino acid content equal to breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and intracellular signalling pathways.

Twenty-four patients will be block-randomized by gender in this parallel-group, randomized, double-blind, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or saline. Metabolism before and after the intervention will be assessed by palmitate- and amino acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a measure of cellular activity.

With this study we hope to find evidence for anabolic effects of intravenous amino acids in j-pouch surgery for ulcerative colitis. The perspective is a potential for primary prophylaxis of surgical complications, reduction in the length of hospitalization, and subsequently optimized long-term functional outcome of the pouch.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Ileal Pouch-anal Anastomosis for Ulcerative Colitis
  • Dietary Supplement: Vaminolac
    Vaminolac with an amino acid content corresponding humane breast milk.
  • Other: Saline
    Intravenous isotonic saline with a sodium chloride content of 9mg/ml.
  • Active Comparator: Vaminolac
    Intravenous Vaminolac during 3 hours, with an infusion rate of 128ml/h.
    Intervention: Dietary Supplement: Vaminolac
  • Placebo Comparator: Saline
    Intravenous saline during 3 hours, with an infusion rate of 128ml/h.
    Intervention: Other: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with ulcerative colitis who are having an ileal pouch-anal anastomosis performed, 18 < age < 50, written informed consent.

Exclusion Criteria:

  • Inability to understand written Danish, postmenopause, severe asthma, diabetes mellitus, severe rheumatologic disease, severe comorbidity (ASA group III-IV) in general. Acute or progressing liver failure, uremia without possibility for dialysis, phenylketonuria, defects in amino acid metabolism. Participation in scientific studies in the preceding year, where ionizing radiation has been used, including significant x-ray investigations.
Both
18 Years to 50 Years
No
Contact: Anders Mark Christensen, B.Sc. +45 78467712 amch@ki.au.dk
Denmark
 
NCT02084550
1-10-72-48-14
Yes
Anders Mark Christensen, Aarhus University Hospital
Aarhus University Hospital
Not Provided
Not Provided
Aarhus University Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP