Sarcopenia and Cirrhosis

Cirrhosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132962
• Other study ID #: H-4-2012-162
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: October 28, 2015
• Start date: May 2014

Study information

• Verified date: September 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Dietary Supplement:
• Amino acid infusion

Other:
• Bloodsamples, Biopsies.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No