The Natural Killer Cells Regulatory Role Against Hepatic Fibrosis Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery
研究概览
简要总结
This study will determine the role of the NK cells before and after bariatric surgery. The investigators selected patients with NAFLD.
A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.
详细描述
All morbidly obese patients who are candidates for a bariatric procedure in the investigators institution who has a fatty liver in their routine preoperative US will undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry (FACS) analysis.
The investigators will also collect other clinical data including comorbidities (hypertension, diabetes mellitus and hyperlipidemia) in addition to the following routine blood test( complete blood count, creatinine, urea, International normalized ratio, liver function test, HBa1C, cholesterol, HDL, LDL, triglycerides, vitamin D, vitamin B12, potassium, sodium, albumin, bilirubin, C- reactive protein, iron, ferritin and transferrin).
All of the above mentioned tests including the NK cells and the fibroscan will be examined for all participants in 3, 6, 12 months postoperatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •age from 18-65
- •body mass index above 30 with comorbidity or above 35 with or without comorbidity
- •evidence of hepatic fibrosis in routine preoperative US
排除标准
- •patient with known other liver disease such as autoimmune or alcoholic hepatitis
- •patient that take hepatotoxic medication or hormonal treatment
- •active alcohol abuse above 20 gram per day
- •Drug abuse
- •patient refusal
- •pregnancy
结局指标
主要结局
Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery
时间窗: 1 year
NK cells are through to play role in modulating fibrogenesis. They exert an anti-fibrotic effects by Killing activated hepatic stellate Cells; the major cells responsible for fibrosis. NK cells activations are crucial step in inhibiting liver fibrosis. Therefore, their functions are thought to be affected in Obese patients. Our aim is to investigate changes in peripheral Blood NK cells by detecting their cytotoxicity potentials by CD107a (LAMP-1; Lysosomal-associated membrane protein 1) as a marker for activation and analyze them by flow-cytometry. Peripheral Blood NK cells will be obtained from obese patients prior to Bariatric surgery and following 3 months, 6 months and 12 months of the surgery.
次要结局
- To assess the fibrosis downstaging by fibroscan prior and following Bariatric surgery(1 year)