NCT07639684尚未招募不适用
Metabolic Effects of Endoscopic Sleeve Gastroplasty in Obese Adults With Type 2 Diabetes: Evaluation of Glycemic Control, Insulin Use and Obesity Response
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Serious Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Endoscopic Sleeve Gastroplasty (ESG) Procedure
Experimental
干预措施: ESG with OverStitch (Device)
结局指标
主要结局
Serious Adverse Events
时间窗: Through study completion, 12 months post procedure
Serious Adverse Events related to the study procedure and/or study device defined as Grade III or greater according to Clavien-Dindo Classification
Average Change in HbA1c
时间窗: 12 months post procedure
Mean change in HbA1c from baseline to 1-year. If rescue treatment is initiated, the last HbA1c value before initiation of rescue treatment is used for assessment of the primary effectiveness endpoint.
次要结局
- Proportion of Subjects Achieving HbA1c < 7%(12 months post procedure)
研究者
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