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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02591-46 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery Group | Patients with MASLD undergoing bariatric surgery (sleeve gastrectomy or gastric bypass) with an indication for liver biopsy due to suspected MASH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery (Sleeve Gastrectomy or Gastric Bypass) | Procedure | Patients undergoin bariatric surgery with simultaneous liver biopsy to analyze MAMs alterations in liver and PBMCs. Follow-up assessments at 6 and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| MAMs alterations in hepatocytes | Number of MAM contacts in liver cells at baseline (T0) | Baseline (T0) |
| Measure | Description | Time Frame |
|---|---|---|
| MAMs alterations in non-parenchymal liver cells (T0) | Number of MAM contacts in non-parenchymal liver cells at baseline (T0) | Baseline (T0) |
| MAMs alterations in PBMCs (T0, T6, T12 months) | Number of MAM contacts in PBMCs |
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Inclusion Criteria * :
Exclusion Criteria * :
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cyrielle CAUSSY, Pr | Contact | +33 4 78 86 44 48 | +33 | cyrielle.caussy@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Edouard Herriot | Recruiting | Lyon | France | 69003 | France |
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Biobank (blood, urine, faeces) Tissue biobank (adipose tissue, muscle) Tissue biobank (liver)
| 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). | 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). | T0 to T6, T6 to T12, T0 toT12 (months) |
| Correlation between MASH improvement and MAMs changes | Correlation between MASH improvement and MAMs changes | T0-T12 months |
| Centre Hospitalier Lyon Sud, Endocrinologie, Diabète et nutrition | Recruiting | Pierre-Bénite | France | 69495 | France |
|
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013505 | Digestive System Surgical Procedures |
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