ObesityNCT04669470
Bariatric Endoscopy and NAFLD
A study testing bariatric endoscopy, mainly intragastric baloons, plication of stomach too in people with Obesity and NAFLD, run by University of Ostrava at 1 site in Czechia.
Trial summary
Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, NAFLD, Liver Steatosis
- What is being tested?
- bariatric endoscopy, mainly intragastric baloons, plication of stomach too
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2020to 31 Dec 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for participation in this study, subjects must conform to the following inclusion criteria:
- Age between 21-64 years;
- BMI >30 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.
Who cannot join
- Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
- Achalasia and any other esophageal motility disorders
- Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
- Hypertension: uncontrolled hypertension during last 3 month
- Severe renal, hepatic, pulmonary disease or cancer;
- GIT stenosis or obstruction
Show all 18Show fewer
- Pregnancy or breastfeeding
- Impending gastric surgery 60 days post intervention;
- Currently participating in other study
- Celiac disease
- History of bariatric surgery
- Chronic or recent acute pancreatitis
- Type 2 diabetes with insuline medication or type 1 diabetes
- Hematologic disease or disease with impairment of hemocoagulation
- Decompensated psychiatric disease
- Autoimmune disease with chronic glucocorticoid or imunosupressive medications
- Uncontroled disease of thyroid gland
- Excesive abuse of addictive substances such alcohol or other
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Department of gastroenterology, hepatology and pancreatology
Ostrava, 70800
Adam Vasura, +420597374191
About this study
Official title: Influence of Bariatric Endoscopy on Clinical Course of NAFLD
Find out how bariatric endocopy will influence 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 in performing a mini-invasive endoscopic procedure and, as a result, in reduced food intake.
Current state of knowledge:
Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.
- Conditions
- Obesity, NAFLD, Liver Steatosis, Liver Fibrosis
- Being tested
- bariatric endoscopy, mainly intragastric baloons, plication of stomach too
- Keywords
- Obesity, NAFLD, liver steatosis, liver fibrosis, bariatric endoscopy, weight lose
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric endoscopy, mainly intragastric baloons, plication of stomach tooProcedure or surgery
bariatric endoscopy, mainly intragastric baloons, plication of stomach too
| Study group | Role | What they receive |
|---|---|---|
| Group with adjustable IGB | Active comparator | Not described Receives: Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too |
| Group with nin-adjustable IGB | Active comparator | Not described Receives: Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
Measured: 24 months
Secondary outcomes (1)
Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome
Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome
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 posted16 Dec 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc, University Hospital Ostrava, Palacky University
- Responsible party
- Sponsor
- Investigators
- Adam Vasura, MD, Study chair, - Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital OstravaEvzen Machytka, Study chair, Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669470
- Sponsor's protocol ID
- 08_RVO-FNOs_2020
- Status last verified
- Nov 2020
- First submitted
- 9 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 30122876
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. 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
- NCT04669470
- Acronym / sponsor ID
- 08_RVO-FNOs_2020
- Conditions
- Obesity, NAFLD, Liver Steatosis, Liver Fibrosis
- Keywords
- Obesity, NAFLD, liver steatosis, liver fibrosis, bariatric endoscopy, weight lose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OstravaUniversity, hospital or other
- Collaborators
- University Hospital Olomouc, University Hospital Ostrava, Palacky University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Dec 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.
Find out how bariatric endocopy will influence 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 in performing a mini-invasive endoscopic procedure and, as a result, in reduced food intake.
Current state of knowledge:
Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with adjustable IGB | Active comparator | Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too |
| Group with nin-adjustable IGB | Active comparator | Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be eligible for participation in this study, subjects must conform to the following inclusion criteria:
- Age between 21-64 years;
- BMI >30 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.
Key exclusion criteria (18 listed)
- Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
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 baloons, plication of stomach toobariatric endoscopy, mainly intragastric baloons, plication of stomach too | Procedure or surgery | Group with adjustable IGB, Group with nin-adjustable IGB |
Primary outcome
Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
Time frame: 24 months
Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
1 secondary outcome
Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome
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 16 Dec 2020.
- 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.
- Individual participant dataSharing planned: Undecided
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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 Vasura, MD study chair
- Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
Evzen Machytka study chair
Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bariatric endoscopy, mainly intragastric baloons, plication of stomach too in people with Obesity and NAFLD, run by University of 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 5 inclusion and 18 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 16 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Vasura (420597374191, obezita@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine 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 NCT04669470, which also lists 3 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 16 Dec 2020.