跳至主要内容
临床试验/NCT04569396
NCT04569396已完成不适用

Effect of Bariatric Surgery on Fatty Liver Disease. A Prospective One-Year Follow-Up Study

University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score

研究概览

简要总结

The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic.

详细描述

The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic. Patients with age above 18 years, BMI > 35-40 kg/m2, and associated with at least one of the complications including hypertension, diabetes, and failure of the current therapies to relieve the symptoms were included in the study. Patients included in the current study do not have a history of excessive alcohol consumption, use of hepatotoxic drugs, infectious liver diseases (i.e. hepatitis A, B, C), and genetic hemochromatosis. A total of 72 patients including n = 26 during 2016, n = 26 during 2017, and n = 20 during 2018 who qualified for bariatric surgeries were included in this observational study. Data related to patients' gender, age (years), weight (kg), height (cm), and associated co-morbidities like diabetes and hypertension were recorded before surgery. BMI (kg/m2), biochemical parameters including triglycerides profile (mmol/L), platelet count (number/L), Gamma glutamyl-transferase (international units - IU/L), albumin concentration (g/L), Alanine amino-transferases (units/L), Aspartate aminotransferases (international units - IU/L), were evaluated following standard procedures. Platelet count, triglycerides, and enzymes were determined using standard procedures.

The biochemical results were compared to the corresponding paired values before surgery and after surgery. The current study was designed to prospectively investigate the effect of bariatric surgeries among non-alcoholic obese individuals from 2016-2018 and one year follow up on liver biochemistry, BMI, non-alcoholic fatty liver disease (NAFLD) fibrosis score, Fibrosis 4 (FIB 4) Index, and Fatty Liver Index (FLI).

The continuous variables were expressed as mean ± standard deviation and median (interquartile range) in case of normal and non-normal distribution, respectively. The Shapiro-Wilk test was used to test for normal distribution. The within-patient changes in clinical parameters (continuous or ordinal variables) from baseline to 1-year after bariatric surgery were compared using the Wilcoxon matched-pairs signed-rank tests for ordinal variables and continuous variables when the change was not normal or using the paired Student's t-test otherwise. The statistical testing was done at the two-tailed α level of 0.05. The data were analyzed using GraphPad Prism Version 8.0.2 (GraphPad Software, Inc., USA).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • age 18 years and above
  • BMI > 35-40 kg/m2
  • hypertension or diabetes or failure of the current therapies to relive the symptoms

排除标准

  • history of excessive alcohol consumption
  • use of hepatotoxic drugs
  • infectious liver diseases (i.e. hepatitis A, B, C)
  • genetic hemochromatosis

结局指标

主要结局

Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score

时间窗: 1 year

NAFLD fibrosis score was determined among the study subjects before and after the surgery.

BMI measurement

时间窗: 1 year

BMI was measured among the study subjects before and after the surgery.

Fibrosis 4 Index

时间窗: 1 year

Fibrosis 4 Index was determined among the study subjects before and after the surgery.

Biochemistry analysis

时间窗: 1 year

Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery (for details please see the Detailed description of the study)

Fatty Liver Index

时间窗: 1 year

Fatty Liver Index was determined among the study subjects before and after the surgery.

次要结局

未报告次要终点

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验