Link between MASH and mitochondrial membrane changes in people having bariatric surgery.
Study of the Link Between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) Alteration in Patients Undergoing Bariatric Surgery - MAMBA
We will test whether changes in mitochondria-associated membranes (MAMs) in liver cells and blood immune cells are linked to MASH in adults undergoing bariatric surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Lyon, France and 1 other locations) |
| Trial ID | NCT06868992 on ClinicalTrials.gov |
What this trial studies
This observational study will collect liver tissue during intraoperative biopsy and peripheral blood mononuclear cells (PBMCs) from adults undergoing sleeve gastrectomy or gastric bypass. Investigators will compare MAM structure and related markers in hepatocytes from patients with MASH versus those without MASH. They will also look for correlations between MAM changes in PBMCs and in liver cells, and examine how MAMs change after bariatric surgery. The work is conducted at hospitals in the Lyon area and uses molecular and histological analyses to characterize MAM alterations.
Who should consider this trial
Good fit: Adults of either sex who have completed multidisciplinary evaluation, are approved for sleeve gastrectomy or gastric bypass, have an indication for intraoperative liver biopsy for suspected MASH, and who provide informed consent are ideal candidates.
Not a fit: Patients with active or past hepatitis B or C, autoimmune hepatitis or autoimmune cholestatic liver disease, or those not undergoing bariatric surgery or lacking an intraoperative biopsy indication are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the study could identify MAM-related changes — potentially detectable in blood cells — that improve diagnosis or monitoring of MASH and help predict liver improvement after bariatric surgery.
How similar studies have performed: Preclinical research and small human studies suggest MAM dysfunction is linked to fatty liver disease, but applying MAM measures in PBMCs and in the setting of bariatric surgery is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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. * Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices * Consommation régulière et/ou excessive d'alcool (plus de 30g/j pour les hommes et plus de 15 g/j pour les femmes) sur une période de plus de 2 ans au cours des 10 dernières années. * History of known HIV infection * History of type 1 diabetes * Pregnant women or breastfeeding mothers\*. * Minor patient * Patient deprived of liberty, * Patients under psychiatric care * Patients admitted to a health or social care establishment for purposes other than research * Mentally unbalanced patients, under supervision or guardianship, * Patients not affiliated to a social security scheme or benefiting from a similar scheme * Patient who does not understand French/ is unable to give consent, * Patient already included in a trial who may interfere with the study
Where this trial is running
Lyon, France and 1 other locations
- Hospices Civils de Lyon - Hôpital Edouard Herriot — Lyon, France, France (Recruiting)
- Centre Hospitalier Lyon Sud, Endocrinologie, Diabète et nutrition — Pierre-Bénite, France, France (Recruiting)
Study contacts
- Study coordinator: Cyrielle CAUSSY, Pr
- Email: cyrielle.caussy@chu-lyon.fr
- Phone: +33 4 78 86 44 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.