- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nice, Francia, 06003
- Service d'Hépato-Gastroentérologie - Hôpital de l'Archet
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Morbid obese patients
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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 ) |
Otro: Control patients
|
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 ) |
Otro: Patients with overweight, steatosis and steatohepatitis
|
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 ) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of the staging of liver fibrosis
Periodo de tiempo: Day 0
|
The investigators determine the stage of liver fibrosis by histological study of biopsies
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Day 0
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Determination of the expression of level of semaphorin
Periodo de tiempo: Day 0
|
The investigators determine by technic of Reverse Transcription Polymerase Chain Reaction (RT-PCR) the expression of level of semaphorin
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Day 0
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Determination of the composition of immunity cells
Periodo de tiempo: Day 0
|
The investigators determine the composition of immunity cells by Immunohistochemical and biochemical analyses (Western Blotting)
|
Day 0
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Albert TRAN, MDPhD, Centre Hospitalier Universitaire de Nice
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11-PP-10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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