Clinical trial NCT05259644: Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Diabetes mellitus
Endoscopy
Surgery
Gut microbiota
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2022-02-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In total 75 patients will be randomized into 3 groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: 6 months
Secondary outcomes:
measure: Change in Glycated Hemoglobin
timeFrame: 6 months
measure: Change in serum glucagon-like peptide 1 (GLP-1)
timeFrame: 6 months
measure: Change in fasting blood glucose
timeFrame: 6 months
Other outcomes:
measure: Change in hsCRP
timeFrame: 6 months
measure: Rehospitalizations
timeFrame: 6 months
measure: Change in the IWQOL (The Impact of Weight on Quality of Life) questionnaire
timeFrame: 6 months
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
References: