Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

Study Overview
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Brief Summary
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The project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Detailed Description
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Bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. Novel endoscopic methods based on the principles of bariatric surgery are also highly effective. No direct randomized comparison of both types of treatment has been performed to date and the mechanisms of action of both procedures are still only partially clarified. The aim of the project is to perform a randomized trial comparing efficacy and safety of three treatment options in patients with obesity: laparoscopic sleeve gastrectomy, endoscopic gastric plication and conservative treatment. A further aim is to characterize the influence of the three treatments on subclinical inflammation, gut microbiota composition and changes of gastrointestinal hormones. The results of the project will describe the efficacy and safety of these procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Official Title
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The Influence of Laparascopic SLeeve gAstrectomy Vs. Endoscopic Gastric Plication on Body weIght, Metabolic pArameters and Microbiota Composition in Patients With Obesity: Randomized, Open-labelled Study (SLAVIA Trial)

Conditions
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Obesity

Intervention / Treatment
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* Device: laparoscopic sleeve gastrectomy
* Other: conservative treatment of obesity
* Device: endoscopic gastric plication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 35 kg/m2 For patients with type 2 diabetes - stable antidiabetic medication > 1 month Age 18-60 years Exclusion Criteria: Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM) Prior gastrointestinal (GIT) surgery interfering with study procedure Severe gastroesophageal reflux, severe GIT motility disorder Active malignancy Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment Acute liver or kidney failure Transplantation of insulin producing tissue Gravidity or lactation Mental disorder Inability to sign informed consent Any other contraindication of bariatric surgery or bariatric endoscopy procedure 6. Acute liver or kidney failure 7. Transplantation of insulin producing tissue 8. Gravidity or lactation 9. Mental disorder 10. Inability to sign informed consent 11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In total 75 patients will be randomized into 3 groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative treatment group<br>Obese patients treated with conservative approach - diet. | Other: conservative treatment of obesity<br>* Diet and exercise<br>|
| Active Comparator: Laparoscopic sleeve gastrectomy<br>Obese patients treated with laparoscopic sleeve gastrectomy. | Device: laparoscopic sleeve gastrectomy<br>* Surgical procedure - laparoscopic sleeve gastrectomy.<br>|
| Active Comparator: endoscopic gastric plication<br>Obese patients treated with endoscopic gastric plication. | Device: endoscopic gastric plication<br>* Endoscopic procedure - endoscopic gastric plication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | To compare the change in body weight after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycated Hemoglobin | To compare the change in glycated hemoglobin after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity | 6 months | 
| Change in serum glucagon-like peptide 1 (GLP-1) | To compare the change in serum glucagon-like peptide 1 (GLP-1) after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity | 6 months | 
| Change in fasting blood glucose | To compare the change in fasting blood glucose after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes mellitus, Endoscopy, Surgery, Gut microbiota