ObesityNCT04895943
Bariatric Endoscopy and NAFLD
An observational study of Obesity and NAFLD, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, NAFLD, Liver Steatosis
- What is being tested?
- bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 29 Apr 2021to 31 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients undergoing bariatric endoscopy procedure.
Who may be able to join
- Age between 21-70 years
- BMI >27 Kg/m2
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations
- Must be able to understand and be willing to provide written informed consent
- Patient living within radio range 300 km from the study center
- Failure of the cognitive-behavioral approach to weight reduction
Who cannot join
- Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
- BMI <27
- History of gastric surgery.
- Previous technical difficulties in gastric and duodenal endoscopy or inability to perform endoscopy
- History of GIT diseases such as achalasia, esophageal motility disorders, severe esophagitis or gastritis, the recent history of ulcers, history of steatosis or obstruction in the GIT
- Proven celiac disease
Show all 21Show fewer
- Previous irreversible endoscopic procedures and surgical treatment of obesity
- Chronic and acute pancreatitis
- Active or chronic infectious hepatitis
- Known liver disease or suspected PBC, PSC, autoimmune hepatitis, alpha1-antitrypsin deficiency, Wilson's disease, hereditary hemochromatosis, known cirrhosis or history of hepatic decompensation, AST or ALT> 5-8x ULN
- Type 1 or type 2 diabetes with insulin
- History of malignant disease
- Specific genetic or hormonal disorders associated with obesity (Prader-Willi syndrome, MC4R mutations, etc.)
- Serious disorders of blood clotting and hematopoiesis
- Severe forms of psychiatric illness (endogenous depression, schizophrenia, suicidal tendencies, psychosis)
- Uncontrolled hypertension (systolic BP> 150 mm Hg or diastolic BP> 100 mm Hg) or severe heart disease (severe cardiac dysfunction, etc.)
- Serious autoimmune diseases or long-term use treated with glucocorticoids or immunosuppressive therapy
- Disorders of thyroid function unresponsive to processing.
- Renal impairment with GFR <60 ml / min / 1.73 m2, or albumin excretion> 1000 mg / day
- Substance use including excessive alcohol use (> 21 units / week for men and> 14 units / week for women, - 1 unit (250ml 12 ° or 330ml 10 ° beer; 100ml wine; 25ml = small spirits of spirits))
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Influence of Bariatric Endoscopy on Clinical Course of NAFLD
Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.
Read the detailed description
The study will test and investigate the impact of bariatric endoscopy (various types of intragastric balloons, endoscopic sleeve gastroplasty, aspiration therapy) on components of the metabolic syndrome in obese patients, especially on influencing non-alcoholic steatosis and steatohepatitis and signs of liver fibrotization and weight reduction. The method consists of performing a mini-invasive endoscopic procedure and, as a result, reduced food intake.
- Conditions
- Obesity, NAFLD, Liver Steatosis, Liver Fibrosis
- Being tested
- bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
- Keywords
- Obesity, NAFLD, liver steatosis, liver fibrosis, bariatric endoscopy, weight loss
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric endoscopy, mainly intragastric balloons, plication of the stomach tooProcedure or surgery
bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
bariatric endoscopy, mainly intragastric balloons, plication of the stomach tooProcedure or surgery
bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
| Study group | Role | What they receive |
|---|---|---|
| Group with adjustable IGB | Not described Receives: Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too | |
| Group with non-adjustable IGB | Not described Receives: Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
Measured: 24 months
Secondary outcomes (8)
Influence of bariatric endoscopy on change of weight
Influence of bariatric endoscopy on change of weight
Measured: 24 months
Influence of bariatric endoscopy on change of anthropometric parameters
Influence of bariatric endoscopy on change of anthropometric parameters
Measured: 24 months
Anthropometric changes - weight (kg), BMI (kg/m2)
Anthropometric changes - weight (kg), BMI (kg/m2)
Measured: 24 months
Anthropometric changes - waist and hip circumference (cm)
Anthropometric changes - waist and hip circumference (cm)
Measured: 24 months
Nutritional changes (eating habits) - questionnaire survey.
Nutritional changes (eating habits) - questionnaire survey.
Measured: 24 months
Components of the metabolic syndrome - blood pressure (mm/Hg)
Components of the metabolic syndrome - blood pressure (mm/Hg)
Measured: 24 months
Components of the metabolic syndrome - waist circumference (cm)
Components of the metabolic syndrome - waist circumference (cm)
Measured: 24 months
Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)
Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start29 Apr 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Vašura, MD, Study chair, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895943
- Sponsor's protocol ID
- 04_RVO-FNOs_2021
- Status last verified
- Jan 2024
- First submitted
- 5 May 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
Fakhry TK, Mhaskar R, Schwitalla T, Muradova E, Gonzalvo JP, Murr MM. Bariatric surgery improves nonalcoholic fatty liver disease: a contemporary systematic review and meta-analysis. Surg Obes Relat Dis. 2019 Mar;15(3):502-511. doi: 10.1016/j.soard.2018.12.002. Epub 2018 Dec 6.
PubMed 30683512Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct;21(10):1499-507. doi: 10.1007/s11695-011-0424-z.
PubMed 21553304Leoni S, Tovoli F, Napoli L, Serio I, Ferri S, Bolondi L. Current guidelines for the management of non-alcoholic fatty liver disease: A systematic review with comparative analysis. World J Gastroenterol. 2018 Aug 14;24(30):3361-3373. doi: 10.3748/wjg.v24.i30.3361.
PubMed 30122876Vasura A, Machytka E, Urban O, Machackova J, Pavliska L, Berka Z, Svagera Z, Buzga M. Effect of bariatric endoscopy on liver fibrosis and steatosis and the course of NAFLD - a prospective interventional study. Ann Hepatol. 2025 Jan-Jun;30(1):101765. doi: 10.1016/j.aohep.2024.101765. Epub 2024 Dec 12.
PubMed 39674369
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bariatric Endoscopy on Clinical Course of NAFLD
- ClinicalTrials.gov ID
- NCT04895943
- Acronym / sponsor ID
- 04_RVO-FNOs_2021
- Conditions
- Obesity, NAFLD, Liver Steatosis, Liver Fibrosis
- Keywords
- Obesity, NAFLD, liver steatosis, liver fibrosis, bariatric endoscopy, weight loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 May 2021 (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.
Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.
Detailed description
The study will test and investigate the impact of bariatric endoscopy (various types of intragastric balloons, endoscopic sleeve gastroplasty, aspiration therapy) on components of the metabolic syndrome in obese patients, especially on influencing non-alcoholic steatosis and steatohepatitis and signs of liver fibrotization and weight reduction. The method consists of performing a mini-invasive endoscopic procedure and, as a result, reduced food intake.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with adjustable IGB | – | Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too |
| Group with non-adjustable IGB | – | Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients undergoing bariatric endoscopy procedure.
Key inclusion criteria (6 listed)
- Age between 21-70 years
- BMI >27 Kg/m2
- Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations
- Must be able to understand and be willing to provide written informed consent
- Patient living within radio range 300 km from the study center
Key exclusion criteria (21 listed)
- Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
- BMI <27
- History of gastric surgery.
- Previous technical difficulties in gastric and duodenal endoscopy or inability to perform endoscopy
- History of GIT diseases such as achalasia, esophageal motility disorders, severe esophagitis or gastritis, the recent history of ulcers, history of steatosis or obstruction in the GIT
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 |
|---|---|---|
| bariatric endoscopy, mainly intragastric balloons, plication of the stomach toobariatric endoscopy, mainly intragastric balloons, plication of the stomach too | Procedure or surgery | Group with adjustable IGB |
| bariatric endoscopy, mainly intragastric balloons, plication of the stomach toobariatric endoscopy, mainly intragastric balloons, plication of the stomach too | Procedure or surgery | Group with non-adjustable IGB |
Primary outcome
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
Time frame: 24 months
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
8 secondary outcomes
Influence of bariatric endoscopy on change of weight
Time frame: 24 months
Influence of bariatric endoscopy on change of anthropometric parameters
Time frame: 24 months
Anthropometric changes - weight (kg), BMI (kg/m2)
Time frame: 24 months
Anthropometric changes - waist and hip circumference (cm)
Time frame: 24 months
Nutritional changes (eating habits) - questionnaire survey.
Time frame: 24 months
Components of the metabolic syndrome - blood pressure (mm/Hg)
Time frame: 24 months
Components of the metabolic syndrome - waist circumference (cm)
Time frame: 24 months
Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 30683512Fakhry TK, Mhaskar R, Schwitalla T, Muradova E, Gonzalvo JP, Murr MM. Bariatric surgery improves nonalcoholic fatty liver disease: a contemporary systematic review and meta-analysis. Surg Obes Relat Dis. 2019 Mar;15(3):502-511. doi: 10.1016/j.soard.2018.12.002. Epub 2018 Dec 6.
- Background: PubMed 21553304Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct;21(10):1499-507. doi: 10.1007/s11695-011-0424-z.
- Background: PubMed 30122876Leoni S, Tovoli F, Napoli L, Serio I, Ferri S, Bolondi L. Current guidelines for the management of non-alcoholic fatty liver disease: A systematic review with comparative analysis. World J Gastroenterol. 2018 Aug 14;24(30):3361-3373. doi: 10.3748/wjg.v24.i30.3361.
- Derived from this study: PubMed 39674369Vasura A, Machytka E, Urban O, Machackova J, Pavliska L, Berka Z, Svagera Z, Buzga M. Effect of bariatric endoscopy on liver fibrosis and steatosis and the course of NAFLD - a prospective interventional study. Ann Hepatol. 2025 Jan-Jun;30(1):101765. doi: 10.1016/j.aohep.2024.101765. Epub 2024 Dec 12.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided 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.
Adam Vašura, MD study chair
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 Obesity and NAFLD, 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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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?
Results are not available in the source record.
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?
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis (time frame: 24 months). 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 NCT04895943, which also lists 4 linked publications.
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 18 Jan 2024.