NCT05516576招募中不适用
Endoscopic Sutured Gastroplasty with Endomina® Device Versus Standard of Care in Patients with Type 2 Diabetes and Class I Obesity: a Multi-center, Randomized Controlled Trial
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity
研究概览
简要总结
The primary objective of this study is to assess the efficacy of endoscopic gastric reduction with the endomina® device, in combination with standard of care, compared to standard of care alone, on the remission of diabetes 24 months after surgery, in patients with type-2 diabetes and class I obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 years;
- •Recently diagnosed Type 2 Diabetes (<= 10 years):
- •HbA1c < 9%:
- •Under non-insulin anti-diabetic treatment, i.e., metformin, sulfonylurea, glinide, DPP4i, GLP1-RA, SGLT2i, alone or in combination
- •Anti-diabetic therapy stable during the last 3 months before inclusion
- •BMI between 30-34.9 kg/m² with adaptation for Asian population 27.5-32.5kg/m²
- •Must be able to comply with all study requirements for the duration of the study as outlined in the protocol (including compliance to randomization treatment, dietary follow up, visits schedule and all study specific procedures);
- •Must be able to understand and be willing to provide written informed consent.
排除标准
- •Contra-indication to the use of endomina® and TAPES according to their Instruction for Use (IFU).
- •Type I diabetes characterized by C peptide <0.2 nmol/l or presence of anti-GAD, anti IA2, anti-ZNT8
- •Unstable diabetic retinopathy
- •Severe kidney (stage 4-5), hepatic (child B and C cirrhosis), pulmonary disease or cancer (cancer in the past 5 years);
- •Short-term prognosis due to a proven serious comorbidity including severe macrovascular complications and / or a limited life expectancy (<5 years)
- •Contra-indication to endoscopic gastroplasty (...)
- •Impending gastric surgery 60 days post intervention;
- •Participant involved in another interventional clinical study
- •Patients having alcoholic or drug addiction;
- •Patients having a severe mental illness such as psychosis, bipolar disorders, severe, current depression or eating disorder such as bulimia nervosa or binge eating disorder;
- •Person deprived of liberty by judicial order
- •Person under guardianship or curatorship
结局指标
主要结局
Remission of diabetes after endoscopic gastroplasty with endomina, in patients with type-2 diabetes and class I obesity
时间窗: 24 months
Remission is defined as HbA1c \< 6.5% without antidiabetic drug for at least 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Endoscopic Gastric Reduction for Weight ManagementObesityNCT01682733Mayo Clinic10
撤回
2 期
Endoscopic sutured gastroplasty with endomina in diabetic, obese patients * prospective interventional study1001265310017998DiabetesNL-OMON51445niversitair Medisch Centrum40
已完成
不适用
Endoscopic Sleeve GastroplastyMorbid ObesityNCT02948621IHU Strasbourg80
已完成
不适用
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea SyndromeSleep Apnea SyndromesOverweight and ObesityNCT04979234Erasme University Hospital10
进行中（未招募）
不适用
A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative ColitisObesityUlcerative ColitisNCT05739162Mayo Clinic2