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Sarcopenia and Cirrhosis

Primary Purpose

Cirrhosis

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Amino acid infusion

Bloodsamples, Biopsies.

About this trial

This is an interventional basic science trial for Cirrhosis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Healthy controls

Cirrhosis

Arm Description

Amino acid infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02132962

First Posted

April 30, 2014

Last Updated

October 28, 2015

Sponsor

Rigshospitalet, Denmark

Collaborators

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02132962

Brief Title

Sarcopenia and Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Hvidovre University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy controls

Arm Type

Active Comparator

Arm Description

Amino acid infusion

Arm Title

Cirrhosis

Arm Type

Active Comparator

Arm Description

Amino acid infusion

Intervention Type

Dietary Supplement

Intervention Name(s)

Amino acid infusion

Intervention Type

Other

Intervention Name(s)

Bloodsamples, Biopsies.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

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Sarcopenia and Cirrhosis

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