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Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
Compare functional improvement of T2D using the Magnet System in duodeno-ileostomy for intestinal diversion versus semaglutide in eligible participants with obesity (BMI 30 - 40 kg/m2) and T2D (HbA1c ≥ 6.5%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Arm | Active Comparator | Magnet System |
|
| Medication Arm | Active Comparator | Semaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnet System | Device | Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional improvement of T2D: HbA1c | Day 360 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Griffin Vincent, PhD, MA | Contact | +1 763-200-1416 | clinical@gtmetabolic.com | |
| Josh Schumacher | Contact | +1 763-200-1416 | clinical@gtmetabolic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmount Surgical Center | Recruiting | Westmount | Quebec | H3Z 2P9 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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1:1 randomization of Surgery (MagDI System) versus Medication (semaglutide). At Day 360, subjects in the Medication arm will have the option to crossover to the Surgery Arm.
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| 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) |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |