Obesity
Conditions
Keywords
Obesity, Diabetes mellitus, Endoscopy, Surgery, Gut microbiota
Brief summary
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
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.
Interventions
DEVICElaparoscopic sleeve gastrectomy
Surgical procedure - laparoscopic sleeve gastrectomy.
OTHERconservative treatment of obesity
Diet and exercise
Endoscopic procedure - endoscopic gastric plication
Sponsors
Institute for Clinical and Experimental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
In total 75 patients will be randomized into 3 groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. BMI \> 35 kg/m2 2. For patients with type 2 diabetes - stable antidiabetic medication \> 1 month 3. Age 18-60 years
Exclusion criteria
1. Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM) 2. Prior gastrointestinal (GIT) surgery interfering with study procedure 3. Severe gastroesophageal reflux, severe GIT motility disorder 4. Active malignancy 5. Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 6 months | To compare the change in body weight after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin | 6 months | To compare the change in glycated hemoglobin after laparoscopic sleeve gastrectomy ve. endoscopic gastric plication and endoscopic gastric plication vs. conservative treatment of obesity |
| Change in serum glucagon-like peptide 1 (GLP-1) | 6 months | 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 |
| Change in fasting blood glucose | 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalizations | 6 months | To compare the rate of rehospitalizations after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity |
| Change in the IWQOL (The Impact of Weight on Quality of Life) questionnaire | 6 months | 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 |
| Change in hsCRP | 6 months | 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 |
Countries
Czechia
Contacts
Primary ContactJan Kral, MD
Backup ContactEven Machytka, MD
Outcome results
None listed