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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative treatment group | Active Comparator | Obese patients treated with conservative approach - diet. |
|
| Laparoscopic sleeve gastrectomy | Active Comparator | Obese patients treated with laparoscopic sleeve gastrectomy. |
|
| endoscopic gastric plication | Active Comparator | Obese patients treated with endoscopic gastric plication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sleeve gastrectomy | Device | Surgical procedure - laparoscopic sleeve gastrectomy. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hsCRP | To compare the change in high sensitive C reactive protein as a marker of low grade inflammation after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity | 6 months |
| Rehospitalizations |
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Kral, MD | Contact | +420236053280 | jan.kral@ikem.cz | |
| Even Machytka, MD | Contact | +420236053280 | even.machytka@ikem.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine | Prague | 14021 | Czechia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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In total 75 patients will be randomized into 3 groups.
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| conservative treatment of obesity | Other | Diet and exercise |
|
| endoscopic gastric plication | Device | Endoscopic procedure - endoscopic gastric plication |
|
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 |
To compare the rate of rehospitalizations after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity
| 6 months |
| Change in the IWQOL (The Impact of Weight on Quality of Life) questionnaire | To compare the change in quality of life as assessed by the IWQOL (The Impact of Weight on Quality of Life) questionnaire after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity | 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |