SLAVIA: Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

• Sponsor: Institute for Clinical and Experimental Medicine (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05259644
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: laparoscopic sleeve gastrectomy; Other: conservative treatment of obesity; Device: endoscopic gastric plication	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: In total 75 patients will be randomized into 3 groups.In total 75 patients will be randomized into 3 groups.
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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)
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conservative treatment group Obese patients treated with conservative approach - diet.	Other: conservative treatment of obesity; Diet and exercise
Active Comparator: Laparoscopic sleeve gastrectomy Obese patients treated with laparoscopic sleeve gastrectomy.	Device: laparoscopic sleeve gastrectomy; Surgical procedure - laparoscopic sleeve gastrectomy.
Active Comparator: endoscopic gastric plication Obese patients treated with endoscopic gastric plication.	Device: endoscopic gastric plication; Endoscopic procedure - endoscopic gastric plication

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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 Outcome Measures

1. 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

2. Rehospitalizations [6 months]

   To compare the rate of rehospitalizations after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Clinical and Experimental Medicine	Prague		Czechia	14021

Sponsors and Collaborators

• Institute for Clinical and Experimental Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julius Spicak, prof. MUDr. Julius Spicak, CSc., Institute for Clinical and Experimental Medicine
• ClinicalTrials.gov Identifier: NCT05259644
• Other Study ID Numbers: NU21-01-00096
• First Posted: Feb 28, 2022
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julius Spicak, prof. MUDr. Julius Spicak, CSc., Institute for Clinical and Experimental Medicine: Obesity; Diabetes mellitus; Endoscopy; Surgery; Gut microbiota
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Feb 28, 2022