NCT01060813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 21, 2015

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

February 1, 2010

Last Update Submit

August 20, 2015

Conditions

Cirrhosis

Keywords

cirrhosisexerciseleucinglutamine synthetase

Outcome Measures

Primary Outcomes (1)

  • glutamine synthetase activity

    three months

Secondary Outcomes (1)

  • quality of life

    three months

Study Arms (2)

Exercise + Leucine

ACTIVE COMPARATOR

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

Dietary Supplement: Leucine supplements

Leucine without exercise

ACTIVE COMPARATOR

patients will receive leucine 10 g/d po

Dietary Supplement: Leucine supplements

Interventions

Leucine supplementsDIETARY_SUPPLEMENT

leucine supplements

Also known as: No other names
Exercise + LeucineLeucine without exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • compensated liver cirrhosis.

You may not qualify if:

  • hepatocellular carcinoma,
  • active alcoholism (less than 1 year),
  • decompensated cirrhosis,
  • variceal bleeding less than 3 months,
  • contraindication for exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

FibrosisMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • German Soriano, MD, PhD

    Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. German Soriano Pastor

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

August 21, 2015

Record last verified: 2011-09

Locations

ES(1)