Sarcopenia and Cirrhosis

Not Applicable

Completed

• Conditions: Cirrhosis
• Interventions: Dietary Supplement: Amino acid infusion; Other: Bloodsamples, Biopsies.

• Registration Number: NCT02132962
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Status Verified: 2015-09
• Primary Completion: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Amino acid infusion	Amino acid infusion
Cirrhosis	Bloodsamples, Biopsies.	Amino acid infusion
Healthy controls	Bloodsamples, Biopsies.	Amino acid infusion
Cirrhosis	Amino acid infusion	Amino acid infusion

Primary Outcome Measures

Name	Time	Method
Turnover of phenylalanine and tyrosine in skeletal muscle tissue during amino acid infusion. Inflammatory markers. Protein signaling cascade.	24 weeks	Using stable isotope tracer technique with infusion of phenylalanine and tyrosine tracer.; Using ELISA technique. Using PCR and western blot technique.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark