Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)

Официальное название

Metabolic Effects of Endoscopic Sleeve Gastroplasty in Obese Adults With Type 2 Diabetes: Evaluation of Glycemic Control, Insulin Use and Obesity Response

Обзор

The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.

Вмешательства

• Устройство ESG with OverStitch
  Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.

Первичные конечные точки

• Serious Adverse Events [Срок оценки: Through study completion, 12 months post procedure]
• Average Change in HbA1c [Срок оценки: 12 months post procedure]

Вторичные конечные точки (1)

• Proportion of Subjects Achieving HbA1c < 7% [Срок оценки: 12 months post procedure]

Критерии участия

Критерии включения

• Willing and able to provide written informed consent to participate in the study
• Age ≥ 22 years
• BMI 30 - 50 kg/m2
• HbA1c 7.5 - 10.5%
• Type 2 Diabetes treated with incretin-based medication (aka GLP-1RA agonist or GLP-1RA/GIP dual agonist) at a stable, maximal tolerated dose for a minimum of 6 months +/- any other oral glucose lowering medications AND intention to initiate insulin therapy for glycemic management
• Stable weight (< 5% TBW) within the 3 months prior to screening
• Meets the indications for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System, excluding the following but not limited to the following: large hiatal hernia, potential bleeding gastric lesions (e.g. ulcers; erosive gastritis; varices; or vascular malformation), coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
• Declines or is ineligible for metabolic bariatric surgery
• Agrees to abstain from taking any weight loss treatments or supplements that are not part of the lifestyle modification program for a year following the ESG procedure
• Willing and able to comply with the study procedure with standard of care lifestyle modification program and visit schedule.

Критерии исключения

• Diabetes management with insulin. Prior use of insulin for gestational diabetes or short-term use (up to 1 month) in conjunction with an acute condition is acceptable.
• Noncompliance with medication regime for diabetic management
• More than one episode of clinically significant reactive or severe hypoglycemia within the prior 1 year. Reactive hypoglycemia is defined as postprandial hypoglycemia meeting Whipple's Triad; severe hypoglycemia is defined as any hypoglycemic episode requiring assistance from another person to administer carbohydrates, glucagon, or other corrective/resuscitative action
• History of ketoacidosis or hyperosmolar nonketotic coma within the past 1 year
• Has a contraindication for ESG procedure with OverStitch™ or OverStitch NXT™ Endoscopic Suturing System, including but not limited to the following: large hiatal hernia, potential bleeding gastric lesions (e.g. ulcers; erosive gastritis, varices, or vascular malformation), coagulopathy and antiplatelet/anticoagulant therapy that cannot be correct
• Prior gastric surgery, including but not limited to LSG or RYGP
• Any known conditions that impact weight loss or glycemic management
• Chronic systemic steroids or immunosuppressants taken at the time of enrollment or likely required during the study follow-up
• CKD stage 3+, defined as eGFR < 60 mL/min
• Persistent anemia, defined as hemoglobin < 10 g/dL
• Excessive alcohol consumption, defined as meeting or exceeding sex-based heavy drinking limits
• Use within the last three months prior to screening of over the counter or prescribed weight loss supplements / medications, or intent to use any weight loss medications or supplements during the study duration.
• The investigator's medical judgment that the subject is not a candidate for the ESG procedure due to findings, including but not limited to psychological and nutritional evaluation results obtained in the prior 12 months.
• Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding for a year following the ESG procedure.
• Vulnerable subject.
• Current or planned participation in another clinical study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07639684 · E7233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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