Muscles in Liver Diseases (UNIVERSE)
Primary Purpose
Patients Having a Scheduled Abdominal Surgery Procedure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood samples
biopsy of abdominal paroie
Sponsored by

About this trial
This is an interventional basic science trial for Patients Having a Scheduled Abdominal Surgery Procedure
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18 having a scheduled abdominal surgery at Beaujon Hospital
- Patient affiliated to a social security scheme
- Informed patient having signed a consent to participate
Exclusion Criteria:
Primary muscle disease (myopathy, dermatopolymyositis, vasculitis with muscle involvement)
- Amyotrophic drugs: long-term corticosteroid therapy
- Immunosuppressive treatments
- Chronic inflammatory disease (example: Crohn's disease)
- Disease known to cause sarcopenia such as -but not limited to- active extrahepatic neoplasia, polycystic hepatorenal disease
- Gastrointestinal haemorrhage in the 15 days prior to inclusion
- Acute alcoholic hepatitis in the month before inclusion
- Infection during treatment
- Pregnant or breastfeeding woman
- Protected populations: people under guardianship or under guardianship
- Patient not affiliated to a social security scheme
- Patient under AME
- Patient not having signed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
patients without liver disease,
patient with chronic liver disease without cirrhosis,
patients with compensated cirrhosis,
patient with severe cirrhosis
Arm Description
taking blood samples and biopsy of muscular wall
taking blood samples and biopsy of muscular wall
taking blood samples and biopsy of muscular wall
taking blood samples and biopsy of muscular wall
Outcomes
Primary Outcome Measures
describe the muscle changes that occur during liver disease.
Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers
describe the muscle changes that occur during liver disease.
Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and αSMA count
describe the muscle changes that occur during liver disease.
Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin
describe the muscle changes that occur during liver disease.
Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics
Secondary Outcome Measures
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
Circulating concentration of mediators / cells suspected of being responsible for sarcopenia:
extracellular vesicles released by the liver
lymphocyte phenotype potentially modified by sinusoidal endothelial cells of the liver
protein array
Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs
Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:
extracellular vesicles
myokines
Full Information
NCT ID
NCT04758793
First Posted
January 7, 2021
Last Updated
February 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04758793
Brief Title
Muscles in Liver Diseases
Acronym
UNIVERSE
Official Title
Muscles in Liver Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2021 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.
Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.
This study, carried out on a prospective cohort of patients with liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.
Detailed Description
Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, and chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.
Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.
This study, carried out on a prospective cohort of patients with stable liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.
After checking the inclusion criteria, all eligible patients treated at Beaujon Hospital (Clichy) will be invited to participate in the study. After inclusion, clinical and laboratory features (hepatic assessment) will be collected and the blood samples will be taken.
During the surgery, a muscle biopsy will be performed on the incision area. No follow-up is planned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Having a Scheduled Abdominal Surgery Procedure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients without liver disease,
Arm Type
Other
Arm Description
taking blood samples and biopsy of muscular wall
Arm Title
patient with chronic liver disease without cirrhosis,
Arm Type
Other
Arm Description
taking blood samples and biopsy of muscular wall
Arm Title
patients with compensated cirrhosis,
Arm Type
Other
Arm Description
taking blood samples and biopsy of muscular wall
Arm Title
patient with severe cirrhosis
Arm Type
Other
Arm Description
taking blood samples and biopsy of muscular wall
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
3 citrated tubes and 3 EDTA tubes
Intervention Type
Other
Intervention Name(s)
biopsy of abdominal paroie
Intervention Description
a muscle biopsy will be performed on the incision area
Primary Outcome Measure Information:
Title
describe the muscle changes that occur during liver disease.
Description
Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers
Time Frame
1 month after the of inclusion
Title
describe the muscle changes that occur during liver disease.
Description
Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and αSMA count
Time Frame
1 month after the of inclusion
Title
describe the muscle changes that occur during liver disease.
Description
Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin
Time Frame
1 month after the of inclusion
Title
describe the muscle changes that occur during liver disease.
Description
Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics
Time Frame
1 month after the of inclusion
Secondary Outcome Measure Information:
Title
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
Description
Circulating concentration of mediators / cells suspected of being responsible for sarcopenia:
extracellular vesicles released by the liver
lymphocyte phenotype potentially modified by sinusoidal endothelial cells of the liver
protein array
Time Frame
1 month after the of inclusion
Title
Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs
Description
Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:
extracellular vesicles
myokines
Time Frame
1 month after the of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18 having a scheduled abdominal surgery at Beaujon Hospital
Patient affiliated to a social security scheme
Informed patient having signed a consent to participate
Exclusion Criteria:
Primary muscle disease (myopathy, dermatopolymyositis, vasculitis with muscle involvement)
Amyotrophic drugs: long-term corticosteroid therapy
Immunosuppressive treatments
Chronic inflammatory disease (example: Crohn's disease)
Disease known to cause sarcopenia such as -but not limited to- active extrahepatic neoplasia, polycystic hepatorenal disease
Gastrointestinal haemorrhage in the 15 days prior to inclusion
Acute alcoholic hepatitis in the month before inclusion
Infection during treatment
Pregnant or breastfeeding woman
Protected populations: people under guardianship or under guardianship
Patient not affiliated to a social security scheme
Patient under AME
Patient not having signed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
pierre Emmanuel Rautou
Phone
140875283
Ext
33
Email
pierre.emmanuel.rautou@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Enis Kostallari
Phone
140875283
Ext
33
Email
enis.kostallari@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Muscles in Liver Diseases
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