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Muscles in Liver Diseases (UNIVERSE)

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ClinicalTrials.gov Identifier: NCT04758793
Recruitment Status : Not yet recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Patients Having a Scheduled Abdominal Surgery Procedure Other: blood samples Other: biopsy of abdominal paroie Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscles in Liver Diseases
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
patients without liver disease,
taking blood samples and biopsy of muscular wall
Other: blood samples
3 citrated tubes and 3 EDTA tubes

Other: biopsy of abdominal paroie
a muscle biopsy will be performed on the incision area

patient with chronic liver disease without cirrhosis,
taking blood samples and biopsy of muscular wall
Other: blood samples
3 citrated tubes and 3 EDTA tubes

Other: biopsy of abdominal paroie
a muscle biopsy will be performed on the incision area

patients with compensated cirrhosis,
taking blood samples and biopsy of muscular wall
Other: blood samples
3 citrated tubes and 3 EDTA tubes

Other: biopsy of abdominal paroie
a muscle biopsy will be performed on the incision area

patient with severe cirrhosis
taking blood samples and biopsy of muscular wall
Other: blood samples
3 citrated tubes and 3 EDTA tubes

Other: biopsy of abdominal paroie
a muscle biopsy will be performed on the incision area




Primary Outcome Measures :
  1. describe the muscle changes that occur during liver disease. [ Time Frame: 1 month after the of inclusion ]
    Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers

  2. describe the muscle changes that occur during liver disease. [ Time Frame: 1 month after the of inclusion ]
    Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and αSMA count

  3. describe the muscle changes that occur during liver disease. [ Time Frame: 1 month after the of inclusion ]
    Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin

  4. describe the muscle changes that occur during liver disease. [ Time Frame: 1 month after the of inclusion ]
    Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics


Secondary Outcome Measures :
  1. Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle. [ Time Frame: 1 month after the of inclusion ]

    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

  2. Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs [ Time Frame: 1 month after the of inclusion ]

    Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:

    • extracellular vesicles
    • myokines



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758793


Contacts
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Contact: pierre Emmanuel Rautou 140875283 ext 33 pierre.emmanuel.rautou@aphp.fr
Contact: Enis Kostallari 140875283 ext 33 enis.kostallari@gmail.com

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04758793    
Other Study ID Numbers: APHP201215
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases