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

Not yet recruiting

• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Dysfunction-Associated Steatohepatitis; Sleeve Gastrectomy; Gastric Bypass Surgery

• Registration Number: NCT06868992
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MAMs alterations in hepatocytes	Baseline (T0)	Number of MAM contacts in liver cells at baseline (T0)

Secondary Outcome Measures

Name	Time	Method
MAMs alterations in non-parenchymal liver cells (T0)	Baseline (T0)	Number of MAM contacts in non-parenchymal liver cells at baseline (T0)
Changes in hepatic markers of MASLD post-surgery	T0 to T6, T6 to T12, T0 toT12 (months)	Changes in measurements, of Vibration Controlled Transient Elastographt (VCTE) after bariatric surgery (∆T0-T6months, ∆T6-T12months and ∆T0-T12months).
MAMs alterations in PBMCs (T0, T6, T12 months)	Baseline (T0) , T6, T12 months	Number of MAM contacts in PBMCs
Changes in hepatic markers of MASLD post-surgery (2)	T0 to T6, T6 to T12, T0 toT12 (months)	Controlled attenuation Parameter (CAP), after bariatric surgery (∆T0-T6months, ∆T6-T12months and ∆T0-T12months).
Correlation between MASH improvement and MAMs changes	T0-T12 months	Correlation between MASH improvement and MAMs changes

Trial Locations

Locations (2)

Hospices Civils de Lyon - Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Centre Hospitalier Lyon Sud, Endocrinologie, Diabète et nutrition; 🇫🇷 Pierre-B&nite, France