Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820285
• Other study ID #: 11-PP-10
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: October 3, 2017
• Start date: March 2013
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis [NASH]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions.

The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Morbid obese patients

Inclusion Criteria:

• Male and female aged 18-65 years

• Patients with body mass index justifying a surgery for obesity (BMI = 40 kg / m2 or BMI = 35 kg / m2 with comorbidities)

• Consumption of alcohol <20 g / d

• Patients affiliated to a social security insurance

• Patients who signed the informed consent

Exclusion Criteria:

• Hemochromatosis

• Toxic hepatitis

• Deficiency of alpha-1-antitrypsin

• Wilson's disease

• Liver Autoimmune disease (primary biliary cirrhosis, autoimmune hepatitis)

• Hepatitis B, C

• Drug-induced hepatitis

• Presence of HIV status

• Corticosteroids, amiodarone, valproic acid, tamoxifen, anti-inflammatory drugs, lipid lowering agents, testosterone agonists or beta-adrenergic antagonists, orlistat.

• Pregnant or breastfeeding women

• Incarcerated patients or patient under guardianship

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Evaluation of the staging of fibrosis liver
The investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies
• Determine the expression level of semaphorin
The investigators will determine the expression level (gene and protein) of immune semaphorin and their (s) receptor (s) in the liver and subcutaneous and visceral adipose tissue by RT-PCR,
• Determination of the composition of immunity cells
The investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting )

Locations

Country	Name	City	State
France	Service d'Hépato-Gastroentérologie - Hôpital de l'Archet	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the staging of liver fibrosis	The investigators determine the stage of liver fibrosis by histological study of biopsies	Day 0
Primary	Determination of the expression of level of semaphorin	The investigators determine by technic of Reverse Transcription Polymerase Chain Reaction (RT-PCR) the expression of level of semaphorin	Day 0
Primary	Determination of the composition of immunity cells	The investigators determine the composition of immunity cells by Immunohistochemical and biochemical analyses (Western Blotting)	Day 0