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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02820285
Enrollment
148
Registered
2016-06-30
Start date
2013-03-01
Completion date
2016-09-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Fatty Liver Disease

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.

Interventions

OTHEREvaluation of the staging of fibrosis liver

The investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies

OTHERDetermine 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,

OTHERDetermination of the composition of immunity cells

The investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting )

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the staging of liver fibrosisDay 0The investigators determine the stage of liver fibrosis by histological study of biopsies
Determination of the expression of level of semaphorinDay 0The investigators determine by technic of Reverse Transcription Polymerase Chain Reaction (RT-PCR) the expression of level of semaphorin
Determination of the composition of immunity cellsDay 0The investigators determine the composition of immunity cells by Immunohistochemical and biochemical analyses (Western Blotting)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAlbert TRAN, MDPhD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026