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

Официальное название

Magnetic Compression Anastomosis in Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (MAGvMED Study)

Обзор

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

Подробное описание

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%).

Вмешательства

• Устройство Magnet System
  Magnet System for side-to-side magnetic compression anastomosis in a duodeno-ileostomy bipartition
• Препарат 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)

Первичные конечные точки

• Functional improvement of T2D: HbA1c [Срок оценки: Day 360]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Westmount Surgical Center — Westmount

Идентификаторы

NCT: NCT07317115 · GTM-021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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