Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

Obesity Clinical Trial

— SLAVIA  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05259644
• Other study ID #: NU21-01-00096
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Institute for Clinical and Experimental Medicine
• Contact: Jan Kral, MD
• Phone: +420236053280
• Email: jan.kral[@]ikem.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• laparoscopic sleeve gastrectomy
Surgical procedure - laparoscopic sleeve gastrectomy.

Other:
• conservative treatment of obesity
Diet and exercise

Device:
• endoscopic gastric plication
Endoscopic procedure - endoscopic gastric plication

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Rehospitalizations	To compare the rate of rehospitalizations after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity	6 months
Other	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
Primary	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	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
Secondary	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
Secondary	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