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Clinical Trials/NCT02820285
NCT02820285CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nice2 sites in 1 country148 target enrollmentStarted: March 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
148
Locations
2
Primary Endpoint
Determination of the composition of immunity cells

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Morbid obese patients

Other

Intervention: Evaluation of the staging of fibrosis liver (Other)

Morbid obese patients

Other

Intervention: Determine the expression level of semaphorin (Other)

Morbid obese patients

Other

Intervention: Determination of the composition of immunity cells (Other)

Control patients

Other

Intervention: Evaluation of the staging of fibrosis liver (Other)

Control patients

Other

Intervention: Determine the expression level of semaphorin (Other)

Control patients

Other

Intervention: Determination of the composition of immunity cells (Other)

Patients with overweight, steatosis and steatohepatitis

Other

Intervention: Evaluation of the staging of fibrosis liver (Other)

Patients with overweight, steatosis and steatohepatitis

Other

Intervention: Determine the expression level of semaphorin (Other)

Patients with overweight, steatosis and steatohepatitis

Other

Intervention: Determination of the composition of immunity cells (Other)

Outcomes

Primary Outcomes

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)

Evaluation of the staging of liver fibrosis

Time Frame: Day 0

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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