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

Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial

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 Overview

• Status: Unknown
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Dietary supplement: Vaminolac; Other: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Department of Surgery P, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Saline; Intravenous isotonic saline with a sodium chloride content of 9mg/ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenylalanine kinetics	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.	6 hours
Tyrosine kinetics	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.	6 hours
Palmitate balance	Palmitate net balance will be estimated using blood flow and arterio-venous differenves in specific activity	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma changes in hormones and energy sources	Plasma changes in the levels of insulin, glucagon, catecholamines, cortisol, IGF[1], growth hormone, glycerol, urea, glucose	6 hours

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Principal Investigator: Søren Laurberg, MD, DMSc, Department of Surgery P, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Amino-acid, glucose, and electrolyte solution
• Other Study ID Numbers: 1-10-72-48-14