The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.
研究概览
简要总结
The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20≤ age ≤80
- •BMI>35kg/m2
- •Men and women
- •Fatty infiltration in liver ultrasonography
排除标准
- •Alcohol drinking > 140g/week
- •Presence of hepatitis B or C or HIV
- •Known liver disease such as:
- •Wilson's disease
- •hemochromatosis
- •α1-antitrypsin deficiency
- •autoimmune liver disease
- •primary biliary cirrhosis
- •primary sclerosing cholangitis)
结局指标
主要结局
Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.
时间窗: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.
Measurements to be performed to assess liver disease stage at baseline and at 8-12 days and 12, 24 and 48 weeks after surgery: 1. Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, prothrombin-time (PT), international normalized ratio (INR), Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (insulin, glucose, HbA1c). 2. Blood tests of adiponectin (only at baseline and 48 weeks after surgery). 3. Fibroscan test for quantifying liver fibrosis by means of elastography (only at baseline and 48 weeks after surgery). 4. A blood test (FibroMax) for determining the stage and grade of liver damage (only at baseline and at 24 and 48 weeks after surgery). 5. OWLiver® test (a serum based test that can discriminate NAFLD from steatohepatitis using metabolomics) at baseline and 48 weeks after surgery.
次要结局
- Change in cholecystokinin levels before and after the surgery.(Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.)
- Change of postoperative cardiovascular risk compared to baseline.(Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.)