Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00844779
• Other study ID #: 3966
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2009
• Last updated: April 24, 2009
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2009
• Source: University Hospital, Strasbourg, France
• Contact: Ahmed Nassim DALI YOUCEF, PHD
• Phone: (33) 3.69.55.11.84
• Email: ahmed.nassim.dali.youcef[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Procedure:
• Bariatric surgery
Gastric bypass.
• cholecystectomy or benign liver tumor removal
cholecystectomy or benign liver tumor removal

Locations

Country	Name	City	State
France	Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil	Strasbourg
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France,