Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

Study Overview
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Brief Summary
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Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. The diagnosis of these two entities is achieved by histology and neither imaging nor biochemical markers are accurate enough to discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis. Therefore, it is important to distinguish between HS and NASH in order to treat the patients accordingly. In this study, the investigators aim to understand the molecular mechanisms that govern the transition from benign steatosis to complicated NASH. The investigators will analyze by Q-RT-PCR and DNA microarray technologies in the liver of obese patients, the expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and identify the potential signaling pathways responsible for the progression of the disease.

Official Title
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Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches

Conditions
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Liver Disease

Intervention / Treatment
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* Procedure: Bariatric surgery
* Procedure: cholecystectomy or benign liver tumor removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology). Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology). Exclusion Criteria: viral or autoimmune hepatitis hematochromatosis alcohol consumption (> 20 g/24h women, >30 g/24h men) type 1 diabetes inflammation or infection before procedure abnormal hemostasis or coagulation- pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T<br>(n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor. | Procedure: cholecystectomy or benign liver tumor removal<br>* cholecystectomy or benign liver tumor removal<br>|
| A<br>(n=30): with central adiposity, insulin resistance and hepatic steatosis (histology). | Procedure: Bariatric surgery<br>* Gastric bypass.<br>|
| B<br>(n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology). | Procedure: Bariatric surgery<br>* Gastric bypass.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression, Non alcoholic fatty liver disease (NFALD)