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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014