Morbid ObesityNCT04569396
Bariatric Surgery and Fatty Liver Disease
An observational study of Morbid Obesity and Diabetes, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Diabetes, Hypertension
- What is being tested?
- Biochemistry analysis, NAFLD fibrosis score and BMI measurement
- How many people
- 72 participants
- Where
- 1 siteCzechia
- Study dates
- 12 Jan 2016to 16 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age 18 years and above
- BMI > 35-40 kg/m2
- hypertension or diabetes or failure of the current therapies to relive the symptoms
Who cannot join
- history of excessive alcohol consumption
- use of hepatotoxic drugs
- infectious liver diseases (i.e. hepatitis A, B, C)
- genetic hemochromatosis
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: 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.
Read the 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).
- Conditions
- Morbid Obesity, Diabetes, Hypertension
- Being tested
- Biochemistry analysis, NAFLD fibrosis score, BMI measurement, Fibrosis 4 Index, Fatty Liver Index
- Keywords
- non-alcoholic fatty liver disease, bariatric surgery, obesity, liver fibrosis
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Hypertension, Non-alcoholic Fatty Liver Disease, Obesity, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemistry analysisDiagnostic test
Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.
NAFLD fibrosis scoreDiagnostic test
NAFLD fibrosis score was determined among the study subjects before and after the surgery.
BMI measurementOther
BMI was measured among the study subjects before and after the surgery.
Fibrosis 4 IndexDiagnostic test
Fibrosis 4 Index was determined among the study subjects before and after the surgery.
Fatty Liver IndexDiagnostic test
Fatty Liver Index was determined among the study subjects before and after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Biochemistry analysis; Diagnostic Test: NAFLD fibrosis score; Other: BMI measurement; Diagnostic Test: Fibrosis 4 Index; Diagnostic Test: Fatty Liver Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score
NAFLD fibrosis score was determined among the study subjects before and after the surgery.
Measured: 1 year
BMI measurement
BMI was measured among the study subjects before and after the surgery.
Measured: 1 year
Fibrosis 4 Index
Fibrosis 4 Index was determined among the study subjects before and after the surgery.
Measured: 1 year
Fatty Liver Index
Fatty Liver Index was determined among the study subjects before and after the surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start12 Jan 2016
- Primary completion16 Dec 2018
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Daniel Toman, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569396
- Sponsor's protocol ID
- CHIR-06-Fatty_Liver
- Other IDs
- SGS03/LF/2018
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be made available to other researchers upon request.
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.
PubMed 33885048
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Fatty Liver Disease. A Prospective One-Year Follow-Up Study
- ClinicalTrials.gov ID
- NCT04569396
- Acronym / sponsor ID
- CHIR-06-Fatty_Liver
- Conditions
- Morbid Obesity, Diabetes, Hypertension
- Keywords
- non-alcoholic fatty liver disease, bariatric surgery, obesity, liver fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 16 Dec 2018 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Alcoholic Fatty Liver Disease | – | Diagnostic Test: Biochemistry analysis, Diagnostic Test: NAFLD fibrosis score, Other: BMI measurement, Diagnostic Test: Fibrosis 4 Index, Diagnostic Test: Fatty Liver IndexA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age 18 years and above
- BMI > 35-40 kg/m2
- hypertension or diabetes or failure of the current therapies to relive the symptoms
Key exclusion criteria (4 listed)
- history of excessive alcohol consumption
- use of hepatotoxic drugs
- infectious liver diseases (i.e. hepatitis A, B, C)
- genetic hemochromatosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemistry analysisBiochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery. | Diagnostic test | Non-Alcoholic Fatty Liver Disease |
| NAFLD fibrosis scoreNAFLD fibrosis score was determined among the study subjects before and after the surgery. | Diagnostic test | Non-Alcoholic Fatty Liver Disease |
| BMI measurementBMI was measured among the study subjects before and after the surgery. | Other | Non-Alcoholic Fatty Liver Disease |
| Fibrosis 4 IndexFibrosis 4 Index was determined among the study subjects before and after the surgery. | Diagnostic test | Non-Alcoholic Fatty Liver Disease |
| Fatty Liver IndexFatty Liver Index was determined among the study subjects before and after the surgery. | Diagnostic test | Non-Alcoholic Fatty Liver Disease |
Primary outcome
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)
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.
BMI measurement
Time frame: 1 year
BMI was measured among the study subjects before and after the surgery.
Fibrosis 4 Index
Time frame: 1 year
Fibrosis 4 Index was determined among the study subjects before and after the surgery.
Fatty Liver Index
Time frame: 1 year
Fatty Liver Index was determined among the study subjects before and after the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 33885048Toman 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.
- Individual participant dataSharing planned: No. Individual participant data will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Toman, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Diabetes, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemistry analysis (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.