Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGT Metabolic Solutions, Inc.
About this trial
Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Magnet System
- Semaglutide
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov