UnknownNot Applicable

Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity

Czechia75 participantsStarted 2022-02

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. BMI \> 35 kg/m2
✓. For patients with type 2 diabetes - stable antidiabetic medication \> 1 month
✓. Age 18-60 years

Exclusion criteria

✕. 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
✕. Transplantation of insulin producing tissue
✕. Gravidity or lactation

What they're measuring

Change in Body Weight

Timeframe: 6 months

Trial details

NCT IDNCT05259644

SponsorInstitute for Clinical and Experimental Medicine

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-05

Contact for this trial

Jan Kral, MD

+420236053280 jan.kral@ikem.cz

View on ClinicalTrials.gov More Obesity trials