ObesitySLAVIANCT05259644
Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity
A study testing laparoscopic sleeve gastrectomy, conservative treatment of obesity and endoscopic gastric plication in people with Obesity, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- laparoscopic sleeve gastrectomy, conservative treatment of obesity and endoscopic gastric plication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 35 kg/m2
- For patients with type 2 diabetes - stable antidiabetic medication > 1 month
- Age 18-60 years
Who cannot join
- Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
- Prior gastrointestinal (GIT) surgery interfering with study procedure
- Severe gastroesophageal reflux, severe GIT motility disorder
- Active malignancy
- Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
- Acute liver or kidney failure
Show all 12Show fewer
- Transplantation of insulin producing tissue
- Gravidity or lactation
- Mental disorder
- Inability to sign informed consent
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- laparoscopic sleeve gastrectomy, conservative treatment of obesity, endoscopic gastric plication
- Keywords
- Obesity, Diabetes mellitus, Endoscopy, Surgery, Gut microbiota
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyDevice
Surgical procedure - laparoscopic sleeve gastrectomy.
conservative treatment of obesityOther
Diet and exercise
endoscopic gastric plicationDevice
Endoscopic procedure - endoscopic gastric plication
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment group | Active comparator | Obese patients treated with conservative approach - diet. Receives: Other: conservative treatment of obesity |
| Laparoscopic sleeve gastrectomy | Active comparator | Obese patients treated with laparoscopic sleeve gastrectomy. Receives: Device: laparoscopic sleeve gastrectomy |
| endoscopic gastric plication | Active comparator | Obese patients treated with endoscopic gastric plication. Receives: Device: endoscopic gastric plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In total 75 patients will be randomized into 3 groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Julius Spicak, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259644
- Sponsor's protocol ID
- NU21-01-00096
- Acronym
- SLAVIA
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05259644
- Acronym / sponsor ID
- SLAVIA / NU21-01-00096
- Conditions
- Obesity
- Keywords
- Obesity, Diabetes mellitus, Endoscopy, Surgery, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- Feb 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- In total 75 patients will be randomized into 3 groups.
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment group | Active comparator | Other: conservative treatment of obesityObese patients treated with conservative approach - diet. |
| Laparoscopic sleeve gastrectomy | Active comparator | Device: laparoscopic sleeve gastrectomyObese patients treated with laparoscopic sleeve gastrectomy. |
| endoscopic gastric plication | Active comparator | Device: endoscopic gastric plicationObese patients treated with endoscopic gastric plication. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI > 35 kg/m2
- For patients with type 2 diabetes - stable antidiabetic medication > 1 month
- Age 18-60 years
Key exclusion criteria (12 listed)
- Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)
- Prior gastrointestinal (GIT) surgery interfering with study procedure
- Severe gastroesophageal reflux, severe GIT motility disorder
- Active malignancy
- Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic sleeve gastrectomySurgical procedure - laparoscopic sleeve gastrectomy. | Device | Laparoscopic sleeve gastrectomy |
| conservative treatment of obesityDiet and exercise | Other | Conservative treatment group |
| endoscopic gastric plicationEndoscopic procedure - endoscopic gastric plication | Device | endoscopic gastric plication |
Primary outcome
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
3 secondary outcomes
Change in Glycated Hemoglobin
Time frame: 6 months
Change in serum glucagon-like peptide 1 (GLP-1)
Time frame: 6 months
Change in fasting blood glucose
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sleeve gastrectomy, conservative treatment of obesity and endoscopic gastric plication in people with Obesity, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Kral, MD (+420236053280, jan.kral@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.