About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial population
Adult patients with MASLD and obesity for whom an indication for bariatric surgery AND the indication for a per-procedure liver biopsy during bariatric surgery is indicated because of the suspected presence of MASH
Trial design
Cohort
Prospective
Treatments tested in this trial
Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)
Procedure/SurgeryPatients undergoin bariatric surgery with simultaneous liver biopsy to analyze MAMs alterations in liver and PBMCs. Follow-up assessments at 6 and 12 months.
Treatment groups
Trial outcomes
Primary outcomes
MAMs alterations in hepatocytes
Number of MAM contacts in liver cells at baseline (T0)
Secondary outcomes
MAMs alterations in non-parenchymal liver cells (T0)
Number of MAM contacts in non-parenchymal liver cells at baseline (T0)
MAMs alterations in PBMCs (T0, T6, T12 months)
Number of MAM contacts in PBMCs
Changes in hepatic markers of MASLD post-surgery
Changes in measurements, of Vibration Controlled Transient Elastographt (VCTE) after bariatric surgery (∆T0-T6months, ∆T6-T12months and ∆T0-T12months).
Changes in hepatic markers of MASLD post-surgery (2)
Controlled attenuation Parameter (CAP), after bariatric surgery (∆T0-T6months, ∆T6-T12months and ∆T0-T12months).
Sponsors and contacts
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