Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04569396
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2020-09-23
Brief Title:
Bariatric Surgery and Fatty Liver Disease
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Effect of Bariatric Surgery on Fatty Liver Disease A Prospective One-Year Follow-Up Study
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 kgm2 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 ie 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 kgm2 biochemical parameters including triglycerides profile mmolL platelet count numberL Gamma glutamyl-transferase international units - IUL albumin concentration gL Alanine amino-transferases unitsL Aspartate aminotransferases international units - IUL 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 Students t-test otherwise The statistical testing was done at the two-tailed α level of 005 The data were analyzed using GraphPad Prism Version 802 GraphPad Software Inc USA
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 Students t-test otherwise The statistical testing was done at the two-tailed α level of 005 The data were analyzed using GraphPad Prism Version 802 GraphPad Software Inc USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SGS03LF2018 | OTHER_GRANT | University of Ostrava | None |