Clinical trial
Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes
Recruiting now · Not applicable · 1 countries · Registry ID NCT07317115
Recruiting nowNot applicableInterventional
What this study is about
Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM)
Full registry criteria
Inclusion Criteria: * Body Mass Index (BMI) between 30 - 40 kg/m2 and qualifies for obesity treatment at the discretion of the treating investigator (i.e., must be assessed to qualify for both surgery and medication treatment to justify randomization). * Type 2 diabetes (T2D defined as HbA1c ≥ 6.5%). * Participant agrees to refrain from additional metabolic and bariatric (MBS) or reconstructive surgery that would affect body weight for the duration of the study. * Participant agrees to refrain from taking any additional semaglutide-containing or other GLP-1RA medication for the duration of the study, regardless of randomization assignment (i.e., Surgery or Medication). Participant has been informed of the nature of the study and is willing and able to comply with requirements, including randomization, and provides written informed consent to participate in the study. Exclusion Criteria: * Meets any of the contraindications for either treatment arm (Surgery: Magnet System; or Medication: semaglutide), thereby prohibiting randomization * Current or previous metabolic and bariatric surgery (MBS) treatment in the previous 12 months (e.g., sleeve gastrectomy, intragastric balloons, adjustable gastric banding). * Taking or treated with semaglutide, semaglutide-containing medications, or any other GLP-1RA medication in the previous 12 months. * Pregnant, lactating or planning pregnancy during the clinical study and follow-up period. * Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study. * Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, would contraindicate either treatment arm or could limit the participant's ability to participate in the clinical study or to comply with follow-up requirements.
Treatments and study arms
Magnet System
Device
Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition
Semaglutide
Drug
Semaglutide (up to 2.4mg subcutaneous (SQ) injection weekly or dose tolerated according to side effects); a glucagon-like peptide-1 receptor agonist (GLP-1RA)
Primary outcomes
Functional improvement of T2D: HbA1cDay 360
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Westmount Surgical Center🇨🇦 Westmount, Quebec, Canada
Gismonde GnanhoueContact
Michel Gagner, MDPrincipal Investigator