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NCT Number: NCT04569396

Bariatric Surgery and Fatty Liver Disease

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biochemistry analysis

Diagnostic Test

Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.

NAFLD fibrosis score

Diagnostic Test

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

BMI measurement

Other

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

Fibrosis 4 Index

Diagnostic Test

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

Fatty Liver Index

Diagnostic Test

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

Primary outcomes

  1. Biochemistry analysis

    Time frame: 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)

  2. Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score

    Time frame: 1 year

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

  3. BMI measurement

    Time frame: 1 year

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

  4. Fibrosis 4 Index

    Time frame: 1 year

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

  5. Fatty Liver Index

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • University of Ostrava

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 29, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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