Bariatric Surgery and Fatty Liver Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Morbid Obesity, Diabetes, Hypertension

Intervention / Treatment
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* Diagnostic Test: Biochemistry analysis
* Diagnostic Test: NAFLD fibrosis score
* Other: BMI measurement
* Diagnostic Test: Fibrosis 4 Index
* Diagnostic Test: Fatty Liver Index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years and above BMI > 35-40 kg/m2 hypertension or diabetes or failure of the current therapies to relive the symptoms Exclusion Criteria: history of excessive alcohol consumption use of hepatotoxic drugs infectious liver diseases (i.e. hepatitis A, B, C) genetic hemochromatosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Alcoholic Fatty Liver Disease<br>A total of 72 severely or morbidly obese patients with non-alcoholic fatty liver disease and associated co-morbidities like diabetes and hypertension were enrolled into the study. | Diagnostic Test: Biochemistry analysis<br>* Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.<br>Diagnostic Test: NAFLD fibrosis score<br>* NAFLD fibrosis score was determined among the study subjects before and after the surgery.<br>Other: BMI measurement<br>* BMI was measured among the study subjects before and after the surgery.<br>Diagnostic Test: Fibrosis 4 Index<br>* Fibrosis 4 Index was determined among the study subjects before and after the surgery.<br>Diagnostic Test: Fatty Liver Index<br>* Fatty Liver Index was determined among the study subjects before and after the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemistry analysis | 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) | 1 year | 
| Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score | NAFLD fibrosis score was determined among the study subjects before and after the surgery. | 1 year | 
| BMI measurement | BMI was measured among the study subjects before and after the surgery. | 1 year | 
| Fibrosis 4 Index | Fibrosis 4 Index was determined among the study subjects before and after the surgery. | 1 year | 
| Fatty Liver Index | Fatty Liver Index was determined among the study subjects before and after the surgery. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-alcoholic fatty liver disease, bariatric surgery, obesity, liver fibrosis