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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorHospices Civils de Lyon

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)

    Procedure/Surgery

    Patients 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

20 Participants
are divided into 1 treatment group
Group A: Bariatric Surgery Group1 intervention

Trial outcomes

Primary outcomes

1

MAMs alterations in hepatocytes

Number of MAM contacts in liver cells at baseline (T0)

Time frame
Baseline (T0)

Secondary outcomes

1

MAMs alterations in non-parenchymal liver cells (T0)

Number of MAM contacts in non-parenchymal liver cells at baseline (T0)

Time frame
Baseline (T0)
2

MAMs alterations in PBMCs (T0, T6, T12 months)

Number of MAM contacts in PBMCs

Time frame
Baseline (T0) , T6, T12 months
3

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).

Time frame
T0 to T6, T6 to T12, T0 toT12 (months)
4

Changes in hepatic markers of MASLD post-surgery (2)

Controlled attenuation Parameter (CAP), after bariatric surgery (∆T0-T6months, ∆T6-T12months and ∆T0-T12months).

Time frame
T0 to T6, T6 to T12, T0 toT12 (months)

Other outcomes

Sponsors and contacts

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