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

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ClinicalTrials.gov Identifier: NCT01060813
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
German Soriano, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cirrhosis Dietary Supplement: Leucine supplements Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Leucine

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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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 Posted: February 2, 2010    Key Record Dates
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