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OpenTrials
Completed

NCT Number: NCT02820285

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

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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Key information

Conditions

Non Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Hépato-Gastroentérologie - Hôpital de l'Archet

Nice, 06003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of the staging of fibrosis liver

Other

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

Determine the expression level of semaphorin

Other

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

Other

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

)

Primary outcomes

  1. Evaluation of the staging of liver fibrosis

    Time frame: Day 0

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

  2. Determination of the expression of level of semaphorin

    Time frame: Day 0

    The investigators determine by technic of Reverse Transcription Polymerase Chain Reaction (RT-PCR) the expression of level of semaphorin

  3. Determination of the composition of immunity cells

    Time frame: Day 0

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2016
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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