Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis (AMINOPOUCH)
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, assessor-blinded, 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial|
- 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
- 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, growth hormone, glycerol, urea, glucose
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Vaminolac
Intravenous Vaminolac during 3 hours, with an infusion rate of 1,6ml/kilogram bodyweight/h.
Dietary Supplement: Vaminolac
Vaminolac with an amino acid content corresponding humane breast milk.
Placebo Comparator: Saline
Intravenous saline during 3 hours, with an infusion rate of 1,6ml/kilogram bodyweight/h.
Intravenous isotonic saline with a sodium chloride content of 9mg/ml.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02084550
|Contact: Anders M Christensen, BSc||+45 firstname.lastname@example.org|
|Contact: Anders M Christensen, BSc||+45 7846 email@example.com|
|Department of Surgery P, Aarhus University Hospital||Recruiting|
|Aarhus C, Denmark, 8000|
|Contact: Anders M Christensen, BSc +45 7846 7712 firstname.lastname@example.org|
|Sub-Investigator: Anders M Christensen, BSc|
|Principal Investigator:||Søren Laurberg, MD, DMSc||Department of Surgery P, Aarhus University Hospital|