NCT05499949进行中（未招募）不适用
The Franciscus Obesity NASH Study
Franciscus Gasthuis1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery
研究概览
简要总结
The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after bariatric surgery.
In addition, genomics, microbiome and metabolomics analyses will be carried out.
详细描述
After being informed about the study and potential risks, 300 eligible patients will be included.
All participants will undergo lifestyle intervention before bariatric surgery. Extensive cardiometabolic analyses will be carried out. At 5 different moments (twice before and 3 times after bariatric surgery), liver steatosis and elasticity will be evaluate using Fibroscan. For those with an elevated liver fibrosis measurement (TE ≥7.2 kilopascal with M probe or ≥7.95 kilopascal with extra large probe), a laparoscopic liver biopsy will be performed during surgery. Patients will undergo gastric sleeve resection, Roux-n-Y gastric bypass or gastric minibypass.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must fulfil all of the inclusion criteria (unless otherwise specified) for enrolment in the study.
- •Participants must fulfil the criteria of the International Federation for the Surgery of Obesity (IFSO) at screening.
- •Participants must be able to understand the nature of the study and written informed consent must be obtained before any study specific interventions are performed.
- •The cardiac function of a subset group of 30 subjects aged 35 years and older with low transient elastography measurements (≤F1) and no known cardiac disease, hypertension or diabetes mellitus will be compared with a similar number of patients with high transient elastography measurements (≥F3) and no known cardiac disease, hypertension or diabetes mellitus. These patients will be consecutively included.
- •The investigators will perform a liver biopsy during endoscopic bariatric surgery in the patients with an elevated transient elastography measurement (≥F2; suggesting fibrosis and therefore the presence of NASH) in order to correlate the histological diagnosis to the clinical diagnosis based on elastography. In those patients in whom the diagnosis of NASH is confirmed by histology, more detailed follow up in a separate program at the department of gastroenterology is indicated according to the current guidelines.
排除标准
- •Patients who meet any of the following criteria at screening (unless otherwise specified) will be excluded from the study:
- •Participants younger than 18 years or older than 65 years
- •Participants with an established diagnosis of liver pathology like, but not limited to:
- •Hepatitis B
- •Hepatitis C
- •Autoimmune hepatitis
- •Wilson's disease
- •Hemochromatosis
- •Primary biliary cholangitis
- •Primary sclerosing cholangitis
- •Alcoholic liver disease
- •Histologically documented liver cirrhosis (fibrosis stage F4), at screening or in a historical biopsy.
- •Participants with active HIV infection and/or treatment.
- •Participants with diagnosed malignancies with or without active treatment.
- •Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study.
- •The participant does not understand Dutch.
结局指标
主要结局
Change from baseline in liver steatosis (in decibel/meter) 5 years after bariatric surgery
时间窗: baseline (enrolment) and 5 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver steatosis
Change from baseline in liver fibrosis (in kilopascal) 5 years after bariatric surgery
时间窗: baseline (enrolment) and 5 years after bariatric surgery
Transient elastography is a non invasive test evaluating liver fibrosis
次要结局
- Change from baseline in liver fibrosis (in kilopascal) 1 year after bariatric surgery(baseline (enrolment) and 1 year after bariatric surgery)
- Change from baseline in liver fibrosis (in kilopascal) 3 years after bariatric surgery(baseline (enrolment) and 3 years after bariatric surgery)
- Change from baseline in liver steatosis (in decibel/meter) according to the type of bariatric surgery(baseline and 1 and 3 years after bariatric surgery)
- Change from baseline in liver fibrosis (in kilopascal) according to the type of bariatric surgery(baseline and 1 and 3 years after bariatric surgery)
- Change from baseline in liver steatosis (in decibel/meter) according to the genetic profile(baseline and 1 year after surgery)
- Change from baseline in liver fibrosis (in kilopascal) according to the genetic profile(baseline and 1 year after surgery)
- Change from baseline in liver steatosis (in decibel/meter) according to gender and ethnicities(baseline and 1, 3 and 5 years after bariatric surgery)
- Change from baseline in liver fibrosis (in kilopascal) according to gender and ethnicities(baseline and 1, 3 and 5 years after bariatric surgery)
- Change from baseline in liver steatosis liver steatosis (in decibel/meter) according to the gut microbiota(baseline and 1 year after bariatric surgery)
- Change from baseline in liver steatosis liver fibrosis (in kilopascal) according to the gut microbiota(baseline and 1 year after bariatric surgery)
- Association between NAFLD/NASH and vascular dysfunction(baseline)
- Association between NAFLD/NASH and cardiac dysfunction(baseline and 1 year after bariatric surgery)
- Change from baseline in liver steatosis (in decibel/meter) after lifestyle intervention(baseline (enrolment) and 3 months later)
- Change from baseline in liver fibrosis (in kilopascal) after lifestyle intervention(baseline (enrolment) and 3 months later)
- Change from baseline in liver steatosis (in decibel/meter) 1 year after bariatric surgery(baseline (enrolment) and 1 year after bariatric surgery)
- Change from baseline in liver steatosis (in decibel/meter) 3 years after bariatric surgery(baseline (enrolment) and 3 years after bariatric surgery)
- Association between change in NAFLD/NASH and change in cardiac dysfunction(baseline and 1 year after bariatric surgery)
- Correlation between histology and transient elastography measurement in a population with morbid obesity(during surgery)
研究者
研究点 (1)
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