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Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

NCT02084550 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-07-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Søren Laurberg, MD, DMSc · Department of Surgery P, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-07-01
Completion
2017-09-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02084550 on ClinicalTrials.gov