Clinical trial NCT04895943: Bariatric Endoscopy and NAFLD
Official title: Influence of Bariatric Endoscopy on Clinical Course of NAFLD
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
NAFLD
Liver Steatosis
Liver Fibrosis
Keywords: Obesity
NAFLD
liver steatosis
liver fibrosis
bariatric endoscopy
weight loss
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients undergoing bariatric endoscopy procedure.

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 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 24 months
Secondary outcomes:
measure: Influence of bariatric endoscopy on change of weight
timeFrame: 24 months
measure: Influence of bariatric endoscopy on change of anthropometric parameters
timeFrame: 24 months
measure: Anthropometric changes - weight (kg), BMI (kg/m2)
timeFrame: 24 months
measure: Anthropometric changes - waist and hip circumference (cm)
timeFrame: 24 months
measure: Nutritional changes (eating habits) - questionnaire survey.
timeFrame: 24 months
measure: Components of the metabolic syndrome - blood pressure (mm/Hg)
timeFrame: 24 months
measure: Components of the metabolic syndrome - waist circumference (cm)
timeFrame: 24 months
measure: Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)
timeFrame: 24 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Adam Vašura, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Machytka 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.
citation: Leoni 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.