Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Cirrhosis Clinical Trial

Official title:

Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060813
• Other study ID #: IIBSP-AMI-2009-17
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: August 20, 2015
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• compensated liver cirrhosis.

Exclusion Criteria:

• hepatocellular carcinoma,

• active alcoholism (less than 1 year),

• decompensated cirrhosis,

• variceal bleeding less than 3 months,

• contraindication for exercise.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis

Intervention

Dietary Supplement:
• Leucine supplements
leucine supplements

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glutamine synthetase activity		three months	Yes
Secondary	quality of life		three months	Yes