Actively Recruiting
Study of the Link Between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) Alteration in Patients Undergoing Bariatric Surgery - MAMBA
Led by Hospices Civils de Lyon · Updated on 2026-01-15
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the link between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and changes in mitochondria-associated membranes (MAMs) in liver cells and blood cells of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study focuses on understanding how these MAM alterations may play a role in the progression and improvement of MASH. This research is conducted in patients undergoing bariatric surgery and aims to provide insights into liver cell changes related to this condition. Participants are patients with MASLD who are undergoing bariatric surgery, such as sleeve gastrectomy or gastric bypass, and have an indication for liver biopsy due to suspected MASH. During surgery, liver biopsies will be taken to analyze MAM alterations in liver cells and peripheral blood mononuclear cells (PBMCs). Follow-up assessments will be conducted at 6 and 12 months after surgery to monitor changes in MAMs and liver disease markers. Throughout the study, participants will undergo liver biopsies during surgery and blood sample collection at baseline, 6 months, and 12 months. Researchers will examine MAM alterations in different liver cell types and blood cells, and assess the correlation between MAM changes and liver disease improvement. The study will measure changes in liver disease markers over time and track participants' progress up to one year after surgery. The total participation duration includes the surgery and follow-up visits over 12 months.
CONDITIONS
Brief Title
Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male adult patients
- Patients approved for sleeve gastrectomy or gastric bypass after multidisciplinary evaluation
- Patients with an indication for intraoperative liver biopsy due to suspected MASH
- Patients who agree to participate and sign informed consent
- Patients affiliated with a healthcare insurance plan
You will not qualify if you...
- Patients with Hepatitis B (positive HBsAg) or Hepatitis C infection
- Patients with autoimmune hepatitis or autoimmune cholestatic liver disorders
- Patients with Wilson disease or Alpha-1-antitrypsin deficiency
- Patients with Hemochromatosis or drug-induced liver disease
- Patients with bile duct obstruction
- History of medications causing steatosis in past 6 months
- Evidence or history of cirrhosis or portal hypertension
- Regular or excessive alcohol consumption over past 10 years
- History of HIV infection or type 1 diabetes
- Pregnant or breastfeeding women
- Minors
- Patients deprived of liberty or under psychiatric care
- Patients admitted to health or social care for reasons other than research
- Mentally unbalanced patients or under guardianship
- Patients not covered by social security or similar schemes
- Patients unable to understand French or give consent
- Patients already enrolled in conflicting trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo bariatric surgery (sleeve gastrectomy or gastric bypass) with simultaneous liver biopsy to analyze MAMs alterations.
1 visit (in-person, surgery day)
Duration - 12 months
Participants are followed up to assess MAMs alterations and changes in hepatic markers at 6 and 12 months after surgery.
2 visits (in-person) at 6 and 12 months
Trial Site Locations
Total: 2 locations
1
Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon, France, France, 69003
Actively Recruiting
2
Centre Hospitalier Lyon Sud, Endocrinologie, Diabète et nutrition
Pierre-Bénite, France, France, 69495
Actively Recruiting
Research Team
C
Cyrielle CAUSSY, Pr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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