Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH
1 other identifier
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 31, 2026
March 1, 2026
3.5 years
June 20, 2016
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Evaluation of the staging of liver fibrosis
The investigators determine the stage of liver fibrosis by histological study of biopsies
Day 0
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
Determination of the composition of immunity cells
The investigators determine the composition of immunity cells by Immunohistochemical and biochemical analyses (Western Blotting)
Day 0
Study Arms (3)
Morbid obese patients
OTHERControl patients
OTHERPatients with overweight, steatosis and steatohepatitis
OTHERInterventions
The investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies
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,
The investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting )
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'Hépato-Gastroentérologie - Hôpital de l'Archet
Nice, 06003, France
Related Publications (2)
Patouraux S, Rousseau D, Bonnafous S, Lebeaupin C, Luci C, Canivet CM, Schneck AS, Bertola A, Saint-Paul MC, Iannelli A, Gugenheim J, Anty R, Tran A, Bailly-Maitre B, Gual P. CD44 is a key player in non-alcoholic steatohepatitis. J Hepatol. 2017 Aug;67(2):328-338. doi: 10.1016/j.jhep.2017.03.003. Epub 2017 Mar 16.
PMID: 28323124RESULTSans 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.
PMID: 28550439DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert TRAN, MDPhD
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 30, 2016
Study Start
March 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share