Study of the Benefit of Exercise and Aminoacid Supplement... | NCT01060813

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

NCT01060813

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Completed

Last Update Posted

Aug 21, 2015Estimated

Enrollment

17Actual

Phase

Not Applicable

Conditions

Cirrhosis

Interventions

Leucine supplements

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Feb 1, 2010

First Submission Date that Met QC Criteria

Feb 1, 2010

First Posted Date

Feb 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2015

Last Update Posted Date

Aug 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

German Soriano, Dr. German Soriano Pastor, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPrincipal Investigator

Lead Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Leucine supplements	Dietary Supplement	leucine supplements	Exercise + Leucine Leucine without exercise

Measure	Description	Time Frame
glutamine synthetase activity		three months

Measure	Description	Time Frame
quality of life		three months

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
German Soriano, MD, PhD	Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Santa Creu i Sant Pau		Barcelona	Barcelona	08041	Spain

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D009043	Motor Activity

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided