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
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
次要结局
- Proportion of Subjects Achieving HbA1c < 7%(12 months post procedure)
研究者
相似试验
尚未招募
不适用
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)ObesityNCT07449520IHU Strasbourg300
招募中
不适用
Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial CancerNCT07397624Centro di Riferimento Oncologico - Aviano74
尚未招募
不适用
Effects on Non-Alcoholic Steato-Hepatitis (NASH) liver disease, obesity-associated metabolicdisturbances, weight loss, safety and quality of life in adults with NASH and obesity undergoing endoscopic sleeve gastroplasty.on-alcoholic fatty liver diseaseNon-alcoholic fatty liver diseaseMetabolic and Endocrine - Metabolic disordersDiet and Nutrition - ObesityOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonobesityACTRN12618001888257Dr Damian Harding (Chief researcher)10
进行中（未招募）
不适用
Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical StimulatorGastroparesisNCT07526935Baylor Research Institute40
进行中（未招募）
不适用
Impact of GEA Simultaneous to VSG on Post-operative GERDReflux, GastroesophagealObesityNCT07537244Clinica Gastrobese60