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临床试验/NCT02828579
NCT02828579已完成不适用

The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease

Jagiellonian University0 个研究点目标入组 20 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
主要终点
NAFLD

研究概览

简要总结

Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only effective method of achieving weight loss in patients with morbid obesity.

The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty liver disease in patients operated on due to morbid obesity.

详细描述

Investigators include 20 patients qualified for the bariatric procedure with BMI > 40 kg/m2 or a BMI > 35kg/m2 with the presence of comorbidities. The average body weight in the group was 143.85kg with an average BMI of 49.16kg/m2. Before the procedure, investigators evaluated the severity of the non-alcoholic fatty liver disease in each patient using the Sherif Saadeh ultrasound scale. Investigators also evaluated the levels of the liver enzymes. Follow up was performed twelve months after 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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at the age of 18-60, meeting the criteria of qualification for the surgical treatment of obesity, i.e. BMI > 40 kg/m2 or BMI > 35 kg/m2 together with accompanying diseases.

排除标准

  • chronic mental diseases
  • addictions
  • earlier bariatric procedures

结局指标

主要结局

NAFLD

时间窗: 12 months

Ultrasound assessment of the severity of NAFLD with the Sherif-Saadeh scale.

次要结局

  • Comorbidities(12 months after surgery)
  • Liver function impairment(12 months after surgery)
  • Weight loss after bariatric surgery(12 months after surgery)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michał Pędziwiatr

MD, PhD

Jagiellonian University

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