Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

Not Applicable

Not yet recruiting

• Conditions: Obesity
• Interventions: Device: laparoscopic sleeve gastrectomy; Other: conservative treatment of obesity; Device: endoscopic gastric plication

• Registration Number: NCT05259644
• Lead Sponsor: Institute for Clinical and Experimental Medicine

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.

Study Timeline

• Study First Submitted: 2022-01-11
• Status Verified: 2022-02
• Study Start: 2022-02
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2024-05
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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

12. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic sleeve gastrectomy	laparoscopic sleeve gastrectomy	Obese patients treated with laparoscopic sleeve gastrectomy.
Conservative treatment group	conservative treatment of obesity	Obese patients treated with conservative approach - diet.
endoscopic gastric plication	endoscopic gastric plication	Obese patients treated with endoscopic gastric plication.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia