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临床试验/NCT02820285
NCT02820285已完成不适用

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

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2013年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
2
主要终点
Determination of the composition of immunity cells

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Morbid obese patients

Other

干预措施: Evaluation of the staging of fibrosis liver (Other)

Morbid obese patients

Other

干预措施: Determine the expression level of semaphorin (Other)

Morbid obese patients

Other

干预措施: Determination of the composition of immunity cells (Other)

Control patients

Other

干预措施: Evaluation of the staging of fibrosis liver (Other)

Control patients

Other

干预措施: Determine the expression level of semaphorin (Other)

Control patients

Other

干预措施: Determination of the composition of immunity cells (Other)

Patients with overweight, steatosis and steatohepatitis

Other

干预措施: Evaluation of the staging of fibrosis liver (Other)

Patients with overweight, steatosis and steatohepatitis

Other

干预措施: Determine the expression level of semaphorin (Other)

Patients with overweight, steatosis and steatohepatitis

Other

干预措施: Determination of the composition of immunity cells (Other)

结局指标

主要结局

Determination of the composition of immunity cells

时间窗: Day 0

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

Evaluation of the staging of liver fibrosis

时间窗: Day 0

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

Determination of the expression of level of semaphorin

时间窗: Day 0

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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