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CompletedNCT02820285Updated Mar 31, 2026

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

An interventional study of Evaluation of the staging of fibrosis liver and Determine the expression level of semaphorin in Non Alcoholic Fatty Liver Disease, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Non Alcoholic Fatty Liver Disease
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In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 148 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Morbid obese patients

Inclusion criteria

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Other
    Morbid obese patients

    Other: Evaluation of the staging of fibrosis liver · Other: Determine the expression level of semaphorin · Other: Determination of the composition of immunity cells

  • Other
    Control patients

    Other: Evaluation of the staging of fibrosis liver · Other: Determine the expression level of semaphorin · Other: Determination of the composition of immunity cells

  • Other
    Patients with overweight, steatosis and steatohepatitis

    Other: Evaluation of the staging of fibrosis liver · Other: Determine the expression level of semaphorin · Other: Determination of the composition of immunity cells

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 )

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What researchers measure

Primary outcomes

  1. Evaluation of the staging of liver fibrosis

    The investigators determine the stage of liver fibrosis by histological study of biopsies

    Time frame: Day 0

  2. 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

    Time frame: Day 0

  3. Determination of the composition of immunity cells

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

    Time frame: Day 0

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Study locations

1 site
  • Service d'Hépato-Gastroentérologie - Hôpital de l'Archet
    Nice, 06003, France
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References and documents

Publications

  • 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. PubMed 28323124 ↗
  • 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. PubMed 28550439 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02820285
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jun 30, 2016
Start date
Mar 2013
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Mar 31, 2026

Study contacts

Albert TRAN, MDPhD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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