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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060813
First Posted: February 2, 2010
Last Update Posted: August 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
German Soriano, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  Purpose
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.

Condition Intervention
Cirrhosis Dietary Supplement: Leucine supplements

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by German Soriano, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • glutamine synthetase activity [ Time Frame: three months ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: three months ]

Enrollment: 17
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise + Leucine
Patients will receive leucine 10 g/d po + exercise for 3 months
Dietary Supplement: Leucine supplements
leucine supplements
Other Name: No other names
Active Comparator: Leucine without exercise
patients will receive leucine 10 g/d po
Dietary Supplement: Leucine supplements
leucine supplements
Other Name: No other names

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060813


Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: German Soriano, MD, PhD Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau
  More Information

Responsible Party: German Soriano, Dr. German Soriano Pastor, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01060813     History of Changes
Other Study ID Numbers: IIBSP-AMI-2009-17
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: August 21, 2015
Last Verified: September 2011

Keywords provided by German Soriano, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
cirrhosis
exercise
leucin
glutamine synthetase

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes