Metabolic Dysfunction-Associated Steatotic Liver DiseaseMAMBANCT06868992
Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Sleeve Gastrectomy
- What is being tested?
- Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Apr 2025to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Edouard Herriot
Lyon, France, 69003
Maud ROBERT, Dr, +33 4 72 11 62 63 ext. +33, maud.robert@chu-lyon.fr
- Recruiting
Centre Hospitalier Lyon Sud, Endocrinologie, Diabète et nutrition
Pierre-Bénite, France, 69495
Cyrielle CAUSSY, Pr, cyrielle.caussy@chu-lyon.fr
About this study
Official title: Study of the Link Between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) Alteration in Patients Undergoing Bariatric Surgery - MAMBA
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.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Sleeve Gastrectomy, Gastric Bypass Surgery
- Being tested
- Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)
- Keywords
- MASH, MASLD, Mitochondria-Associated Membranes (MAMs), Bariatric Surgery, Hepatic Fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)Procedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery Group | Patients with MASLD undergoing bariatric surgery (sleeve gastrectomy or gastric bypass) with an indication for liver biopsy due to suspected MASH Receives: Procedure: Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAMs alterations in hepatocytes
Number of MAM contacts in liver cells at baseline (T0)
Measured: Baseline (T0)
Secondary outcomes (5)
MAMs alterations in non-parenchymal liver cells (T0)
Number of MAM contacts in non-parenchymal liver cells at baseline (T0)
Measured: Baseline (T0)
MAMs alterations in PBMCs (T0, T6, T12 months)
Number of MAM contacts in PBMCs
Measured: Baseline (T0) , T6, T12 months
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).
Measured: T0 to T6, T6 to T12, T0 toT12 (months)
Changes in hepatic markers of MASLD post-surgery (2)
Controlled attenuation Parameter (CAP), after bariatric surgery (∆T0-T6months, ∆T6-T12months and ∆T0-T12months).
Measured: T0 to T6, T6 to T12, T0 toT12 (months)
Correlation between MASH improvement and MAMs changes
Correlation between MASH improvement and MAMs changes
Measured: T0-T12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Apr 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868992
- Sponsor's protocol ID
- 69HCL24_1096
- Other IDs
- 2024-A02591-46
- Acronym
- MAMBA
- Status last verified
- Jan 2026
- First submitted
- 3 Mar 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Link Between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) Alteration in Patients Undergoing Bariatric Surgery - MAMBA
- ClinicalTrials.gov ID
- NCT06868992
- Acronym / sponsor ID
- MAMBA / 69HCL24_1096
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis, Sleeve Gastrectomy, Gastric Bypass Surgery
- Keywords
- MASH, MASLD, Mitochondria-Associated Membranes (MAMs), Bariatric Surgery, Hepatic Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery Group | – | Procedure: Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)Patients with MASLD undergoing bariatric surgery (sleeve gastrectomy or gastric bypass) with an indication for liver biopsy due to suspected MASH |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (5 listed)
Key exclusion criteria (23 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass)Patients undergoin bariatric surgery with simultaneous liver biopsy to analyze MAMs alterations in liver and PBMCs. Follow-up assessments at 6 and 12 months. | Procedure or surgery | Bariatric Surgery Group |
Primary outcome
MAMs alterations in hepatocytes
Time frame: Baseline (T0)
Number of MAM contacts in liver cells at baseline (T0)
5 secondary outcomes
MAMs alterations in non-parenchymal liver cells (T0)
Time frame: Baseline (T0)
MAMs alterations in PBMCs (T0, T6, T12 months)
Time frame: Baseline (T0) , T6, T12 months
Changes in hepatic markers of MASLD post-surgery
Time frame: T0 to T6, T6 to T12, T0 toT12 (months)
Changes in hepatic markers of MASLD post-surgery (2)
Time frame: T0 to T6, T6 to T12, T0 toT12 (months)
Correlation between MASH improvement and MAMs changes
Time frame: T0-T12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrielle CAUSSY, Pr (+33 4 78 86 44 48 ext. +33, cyrielle.caussy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAMs alterations in hepatocytes (time frame: Baseline (T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.