Status:
ACTIVE_NOT_RECRUITING
Bariatric Endoscopy and NAFLD
Lead Sponsor:
University Hospital Ostrava
Conditions:
Obesity
NAFLD
Eligibility:
All Genders
18-70 years
Brief Summary
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 syndro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04895943
Start Date
April 29 2021
End Date
December 31 2024
Last Update
January 18 2024
Active Locations (1)
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1
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852