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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
German Soriano, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01060813
First received: February 1, 2010
Last updated: September 28, 2011
Last verified: September 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • glutamine synthetase activity [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: January 2010
Estimated 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 1, 2010
Last Updated: September 28, 2011
Health Authority: Spain: Spanish Agency of Medicines
Spain: Ministry of Health

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

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014