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Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA | Clinical Trials | Clareo Health

RECRUITING

Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

Study of the Link Between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

NCT06868992•Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

The main research hypothesis is that alterations in the communication between the endoplasmic reticulum (ER) and the mitochondria at contact sites called mitochondria-associated membranes (MAMs) occurs in different hepatic cell types of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD) and is involved in the progression towards MASH and could also influence the process of improvement of MASH. This study aims to investigate the link between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) in liver cells and peripheral blood mononuclear cells (PBMCs) in patients undergoing bariatric surgery. The primary objective is to analyze MAMs alterations in hepatocytes in MASH patients compared to non-MASH patients. Secondary objectives include evaluating the correlation between MAMs in PBMCs and liver cells and assessing MAMs changes post-bariatric surgery.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•* Female or male adult patients
•* Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a sleeve gastrectomy or a gastric bypass.
•* Patient with an indication Indication for intraoperative liver biopsy due to suspected MASH
•* Patient who agrees to be included in the study and who signs the informed consent form,
•* Patient affiliated to a healthcare insurance plan.

Exclusion Criteria

•* Patient presenting Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
•* Patient presenting previous or current infection with Hepatitis C
•* Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
•* Patient presenting Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
•* Patient presenting Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
•* Patient presenting Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
•* Patient presenting Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
•* Patient presenting Drug-induced liver disease as defined on the basis of typical exposure and history.
•* Patient presenting Bile duct obstruction as shown by imaging studies.
•* History of ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, methotrexate, amiodarone or tetracycline in the previous 6 months.
+13 more criteria

Locations (2)

Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, France, France

Centre Hospitalier Lyon Sud, Endocrinologie, Diabète et nutrition

Pierre-Bénite, France, France

Key Dates

Start Date

April 15, 2025

Primary Completion Date

March 1, 2028

Completion Date

March 1, 2028

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Metabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated SteatohepatitisSleeve GastrectomyGastric Bypass Surgery

Interventions

Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)

PROCEDURE

Contacts

Cyrielle CAUSSY, Pr

CONTACT

+33 4 78 86 44 48 cyrielle.caussy@chu-lyon.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

Inclusion Criteria

Exclusion Criteria

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