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

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Leucine supplements
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring cirrhosis, exercise, leucin, glutamine synthetase

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Exercise + Leucine

Leucine without exercise

Arm Description

Patients will receive leucine 10 g/d po + exercise for 3 months

patients will receive leucine 10 g/d po

Outcomes

Primary Outcome Measures

glutamine synthetase activity

Secondary Outcome Measures

quality of life

Full Information

First Posted
February 1, 2010
Last Updated
August 20, 2015
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT01060813
Brief Title
Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients
Official Title
Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
cirrhosis, exercise, leucin, glutamine synthetase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise + Leucine
Arm Type
Active Comparator
Arm Description
Patients will receive leucine 10 g/d po + exercise for 3 months
Arm Title
Leucine without exercise
Arm Type
Active Comparator
Arm Description
patients will receive leucine 10 g/d po
Intervention Type
Dietary Supplement
Intervention Name(s)
Leucine supplements
Other Intervention Name(s)
No other names
Intervention Description
leucine supplements
Primary Outcome Measure Information:
Title
glutamine synthetase activity
Time Frame
three months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
German Soriano, MD, PhD
Organizational Affiliation
Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

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

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