Bariatric Endoscopy and NAFLD

Influence of Bariatric Endoscopy on Clinical Course of NAFLD

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; NAFLD; Liver Steatosis; Liver Fibrosis
• Intervention / Treatment: Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Obese patients undergoing bariatric endoscopy procedure.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group with adjustable IGB	Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too; bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
Group with non-adjustable IGB	Procedure: bariatric endoscopy, mainly intragastric balloons, plication of the stomach too; bariatric endoscopy, mainly intragastric balloons, plication of the stomach too

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of bariatric endoscopy on change of weight	Influence of bariatric endoscopy on change of weight	24 months
Influence of bariatric endoscopy on change of anthropometric parameters	Influence of bariatric endoscopy on change of anthropometric parameters	24 months
Anthropometric changes - weight (kg), BMI (kg/m2)	Anthropometric changes - weight (kg), BMI (kg/m2)	24 months
Anthropometric changes - waist and hip circumference (cm)	Anthropometric changes - waist and hip circumference (cm)	24 months
Nutritional changes (eating habits) - questionnaire survey.	Nutritional changes (eating habits) - questionnaire survey.	24 months
Components of the metabolic syndrome - blood pressure (mm/Hg)	Components of the metabolic syndrome - blood pressure (mm/Hg)	24 months
Components of the metabolic syndrome - waist circumference (cm)	Components of the metabolic syndrome - waist circumference (cm)	24 months
Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)	Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)	24 months

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Study Chair: Adam Vašura, MD, University Hospital Ostrava

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; NAFLD; liver fibrosis; weight loss; liver steatosis; bariatric endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 04_RVO-FNOs_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No