Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

NCT02084550 | Unknown DMC

• 1 other identifier: 1-10-72-48-14
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Plasma changes in hormones and energy sources

  6 hours

Study Arms (2)

Vaminolac

ACTIVE COMPARATOR

Intravenous Vaminolac during 3 hours, with an infusion rate of 1,6ml/kilogram bodyweight/h.

Dietary Supplement: Vaminolac

Saline

PLACEBO COMPARATOR

Intravenous saline during 3 hours, with an infusion rate of 1,6ml/kilogram bodyweight/h.

Other: Saline

Interventions

Vaminolac DIETARY_SUPPLEMENT

Vaminolac with an amino acid content corresponding humane breast milk.

Vaminolac

Saline OTHER

Intravenous isotonic saline with a sodium chloride content of 9mg/ml.

Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Surgery P, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

amino-acid, glucose, and electrolyte solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Søren Laurberg, MD, DMSc

  Department of Surgery P, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 12, 2014
• Study Start: September 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

DK (1)