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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 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: July 11, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention
Ulcerative Colitis
Dietary Supplement: Vaminolac
Other: Saline

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: September 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084550

Contacts
Contact: Anders M Christensen, BSc +45 78467715 amch@clin.au.dk
Contact: Anders M Christensen, BSc +45 7846 7715 amch@clin.au.dk

Locations
Denmark
Department of Surgery P, Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Anders M Christensen, BSc    +45 7846 7712    amch@clin.au.dk   
Sub-Investigator: Anders M Christensen, BSc         
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Søren Laurberg, MD, DMSc Department of Surgery P, Aarhus University Hospital
  More Information

Responsible Party: Anders Mark Christensen, PhD student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02084550     History of Changes
Other Study ID Numbers: 1-10-72-48-14 
Study First Received: March 5, 2014
Last Updated: July 11, 2016
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Amino-acid, glucose, and electrolyte solution
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 23, 2016