Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity (SLAVIA)

February 17, 2022 updated by: Julius Spicak, Institute for Clinical and Experimental Medicine

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia, 14021
        • Institute for Clinical and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycated Hemoglobin
Time Frame: 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
6 months
Change in serum glucagon-like peptide 1 (GLP-1)
Time Frame: 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
6 months
Change in fasting blood glucose
Time Frame: 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
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hsCRP
Time Frame: 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
6 months
Rehospitalizations
Time Frame: 6 months
To compare the rate of rehospitalizations after laparoscopic sleeve gastrectomy and endoscopic gastric plication vs. conservative treatment of obesity
6 months
Change in the IWQOL (The Impact of Weight on Quality of Life) questionnaire
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU21-01-00096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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