Bariatric Surgery and Fatty Liver Disease

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes; Morbid Obesity
• Intervention / Treatment: Diagnostic test: Biochemistry analysis; Diagnostic test: NAFLD fibrosis score; Other: BMI measurement; Diagnostic test: Fibrosis 4 Index; Diagnostic test: Fatty Liver Index

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 relive the symptoms were included in the study. Patients included in the current study does not have a history of excessive alcohol consumption, use of hepatotoxic drugs, infectious liver diseases (i.e. hepatitis A, B, C) and genetic hemochromatosis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Non-Alcoholic Fatty Liver Disease; 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; Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.; Diagnostic test: NAFLD fibrosis score; NAFLD fibrosis score was determined among the study subjects before and after the surgery.; Other: BMI measurement; BMI was measured among the study subjects before and after the surgery.; Diagnostic test: Fibrosis 4 Index; Fibrosis 4 Index was determined among the study subjects before and after the surgery.; Diagnostic test: Fatty Liver Index; Fatty Liver Index was determined among the study subjects before and after the surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: University of Ostrava
• Investigators: Principal Investigator: Daniel Toman, MD, University Hospital Ostrava

Publications and helpful links

General Publications

• Toman D, Vavra P, Jelinek P, Ostruszka P, Ihnat P, Foltys A, Pelikan A, Roman J. Effect of bariatric surgery on fatty liver disease in obese patients: A prospective one year follow-up study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):195-203. doi: 10.5507/bp.2021.021. Epub 2021 Apr 19.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2016
• Primary Completion (Actual): December 16, 2018
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; liver fibrosis; non-alcoholic fatty liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Liver Diseases; Fatty Liver; Obesity, Morbid
• Other Study ID Numbers: CHIR-06-Fatty_Liver; SGS03/LF/2018 (Other Grant/Funding Number: University of Ostrava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will be made available to other researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No