Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes
NCT ID: NCT07317115
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-31
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Surgery Arm
Magnet System
Magnet System
Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition
Medication Arm
Semaglutide
Semaglutide
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)
Interventions
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Magnet System
Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition
Semaglutide
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GT Metabolic Solutions, Inc.
INDUSTRY
Responsible Party
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Locations
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Westmount Surgical Center
Westmount, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GTM-021
Identifier Type: -
Identifier Source: org_study_id
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