Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

NCT ID: NCT02084550

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Vaminolac

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

Group Type: ACTIVE_COMPARATOR

Vaminolac

Intervention Type: DIETARY_SUPPLEMENT

Vaminolac with an amino acid content corresponding humane breast milk.

Saline

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

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

Interventions

Vaminolac

Vaminolac with an amino acid content corresponding humane breast milk.

Intervention Type: DIETARY_SUPPLEMENT

Saline

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anders Mark Christensen

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Søren Laurberg, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery P, Aarhus University Hospital

Locations

Department of Surgery P, Aarhus University Hospital

Aarhus C, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-48-14

Identifier Type: -

Identifier Source: org_study_id