Bariatric Endoscopy and NAFLD

University Hospital Ostrava

Status

Active, not recruiting

Conditions

Liver Fibrosis

Obesity

NAFLD

Liver Steatosis

Treatments

Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too

Study type

Observational

Funder types

Other

Identifiers

NCT04895943

04_RVO-FNOs_2021

Details and patient eligibility

About

Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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