Bariatric Endoscopy and NAFLD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-29

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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

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Obesity NAFLD Liver Steatosis Liver Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group with adjustable IGB

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

Intervention Type PROCEDURE

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

Group with non-adjustable IGB

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

Intervention Type PROCEDURE

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

Interventions

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No