Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— AMINOPOUCH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02084550
• Other study ID #: 1-10-72-48-14
• Status: Active, not recruiting
• Phase: N/A
• First received: March 5, 2014
• Last updated: July 27, 2017
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2017
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: September 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Surgery P, Aarhus University Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Palmitate balance	Palmitate net balance will be estimated using blood flow and arterio-venous differenves in specific activity	5 hours
Secondary	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