University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852, Czechia
NCT Number: NCT04569396
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Ostrava, Moravian-Silesian Region, 70852, Czechia
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.
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.
Fibrosis 4 Index was determined among the study subjects before and after the surgery.
Fatty Liver Index was determined among the study subjects before and after the surgery.
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)
Time frame: 1 year
NAFLD fibrosis score was determined among the study subjects before and after the surgery.
Time frame: 1 year
BMI was measured among the study subjects before and after the surgery.
Time frame: 1 year
Fibrosis 4 Index was determined among the study subjects before and after the surgery.
Time frame: 1 year
Fatty Liver Index was determined among the study subjects before and after the surgery.
University Hospital Ostrava
Other
Effect of Bariatric Surgery on Fatty Liver Disease. A Prospective One-Year Follow-Up Study
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.
Published trials that share one or more normalized conditions with this study.
NCT02931292
Body Weight, Cardiovascular Diseases
View Trial DetailsNCT06268990
Body Weight, Diabetes
Graz, Austria
View Trial DetailsNCT04235829
Body Weight, Body Weight Changes
Jerusalem, Israel
View Trial DetailsNCT01806506
Body Weight, Body Weight Changes
Warsaw, Poland
View Trial Details