Clinical trial NCT02820285: Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH
Official title: Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the staging of liver fibrosis
timeFrame: Day 0
measure: Determination of the expression of level of semaphorin
timeFrame: Day 0
measure: Determination of the composition of immunity cells
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Service d'Hépato-Gastroentérologie - Hôpital de l'Archet
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Albert TRAN, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sans A, Bailly L, Anty R, Sielezenef I, Gugenheim J, Tran A, Gual P, Iannelli A. Baseline Anthropometric and Metabolic Parameters Correlate with Weight Loss in Women 1-Year After Laparoscopic Roux-En-Y Gastric Bypass. Obes Surg. 2017 Nov;27(11):2940-2949. doi: 10.1007/s11695-017-2720-8.