Skip to content

Bariatric Surgery and Fatty Liver Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04569396
Enrollment
72
Registered
2020-09-29
Start date
2016-01-12
Completion date
2019-12-16
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Diabetes, Hypertension

Keywords

non-alcoholic fatty liver disease, bariatric surgery, obesity, liver fibrosis

Brief summary

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

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).

Interventions

DIAGNOSTIC_TESTBiochemistry analysis

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

DIAGNOSTIC_TESTNAFLD fibrosis score

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

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

DIAGNOSTIC_TESTFibrosis 4 Index

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

DIAGNOSTIC_TESTFatty Liver Index

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

Sponsors

University of Ostrava
CollaboratorOTHER
University Hospital Ostrava
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemistry analysis1 yearBiochemistry 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)
Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score1 yearNAFLD fibrosis score was determined among the study subjects before and after the surgery.
BMI measurement1 yearBMI was measured among the study subjects before and after the surgery.
Fibrosis 4 Index1 yearFibrosis 4 Index was determined among the study subjects before and after the surgery.
Fatty Liver Index1 yearFatty Liver Index was determined among the study subjects before and after the surgery.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026