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Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes

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About this study

Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).

Condition
Obesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM)
Tested
Magnet System, Semaglutide
Sponsor
GT Metabolic Solutions, Inc.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Study condition: Obesity (Disorder), Obesity & Overweight, Type 2 Diabetes (T2DM)
  • 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 6

  • 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.

Where

1 site, 1 recruiting

Westmount Surgical Center

Westmount, Quebec, Canada

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.