NCT02132962

Brief Summary

The study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls. The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

October 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

April 30, 2014

Last Update Submit

October 28, 2015

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Turnover of phenylalanine and tyrosine in skeletal muscle tissue during amino acid infusion. Inflammatory markers. Protein signaling cascade.

    Using stable isotope tracer technique with infusion of phenylalanine and tyrosine tracer. Using ELISA technique. Using PCR and western blot technique.

    24 weeks

Study Arms (2)

Healthy controls

ACTIVE COMPARATOR

Amino acid infusion

Dietary Supplement: Amino acid infusionOther: Bloodsamples, Biopsies.

Cirrhosis

ACTIVE COMPARATOR

Amino acid infusion

Dietary Supplement: Amino acid infusionOther: Bloodsamples, Biopsies.

Interventions

Amino acid infusionDIETARY_SUPPLEMENT
CirrhosisHealthy controls
Bloodsamples, Biopsies.OTHER
CirrhosisHealthy controls

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects
  • Diagnosis of cirrhosis, Child-Pugh A, B, C.

You may not qualify if:

  • Acute illness within 3 weeks
  • Ascites collections within 10 days
  • Heart-, kidney, pulmonary disease. Cancer. Type 1 diabetes.
  • Active alkoholdrinking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 7, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2015

Last Updated

October 29, 2015

Record last verified: 2015-09

Locations

DK(1)