NL-OMON53757招募中不适用
Endoscopic application of pulsed electric fields using the Endogenex Generation 2 ReCET* system for duodenal mucosal regeneration for EliMination of INsulin in the treatmENT of type 2 diabetes: a randomized double-blind sham controlled trial to evaluate safety, feasibility and efficacy study - EMINENT-2 study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diagnosed with type 2 diabetes mellitus
- •2. 28 -75 years of age
- •3. On daily long acting insulin dose <= 1 U/kg
- •4. BMI >= 24 and <= 40 kg/m2
- •5. HbA1c <= 8.0% (64 mmol/mol)
- •6. Fasting C-peptide >= 0.2 nmol/L (0.6 ng/ml)
- •7. Willing to comply with study requirements and able to understand and comply
- •with signed informed consent
排除标准
- •1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis 2. Current
- •use of multiple daily doses insulin or insulin pump. 3. Current use of a GLP-1
- •analogue. 4. Known autoimmune disease, as evidenced by a positive Anti-GAD
- •test, including Celiac disease, or pre-existing symptoms of systemic lupus
- •erythematosus, scleroderma or other autoimmune connective tissue disorder 5.
- •Previous GI surgery that could affect the ability to treat the duodenum such as
- •subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar
- •procedures or conditions 6. History of chronic or acute pancreatitis 7. Known
- •active hepatitis or active liver disease 8. Symptomatic gallstones or kidney
- •stones, acute cholecystitis or history of duodenal inflammatory diseases
- •including Crohn*s Disease and Celiac Disease 9. History of coagulopathy, upper
- •gastro-intestinal bleeding conditions such as ulcers, gastric varices,
- •strictures, congenital or acquired intestinal telangiectasia 10. Use of
- •anticoagulation therapy (such as phenprocoumon and acenocoumarol) which cannot
- •be discontinued for 3-5 days before and 48 hours after the procedure and novel
- •oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran)
- •which cannot be discontinued for 48 hours before and 48 hours after the
- •procedure in accordance with the local protocol 11. Use of P2Y12 inhibitors
- •(clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 5 days
- •before and 48 hours after the procedure in accordance with the local protocol.
- •Use of aspirin is allowed. 12. Unable to discontinue NSAIDs (non-steroidal
- •anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
- •13. Taking corticosteroids or drugs known to affect GI motility (e.g.
- •Metoclopramide) 14. Receiving weight loss medications such as Meridia, Xenical,
- •or over the counter weight loss medications 15. Anemia, defined as Hgb < 6.2
- •mmol/l 16. Known history of severe permanent cardiac arrhythmia*s with clinical
- •symptoms 17. Significant cardiovascular disease, including known history of
- •valvular disease or myocardial infarction, heart failure, transient ischemic
- •attack, or stroke within 6 months prior to the screening visit 18. With any
- •implanted electronic devices or duodenal metallic implants 19. eGFR or MDRD <
- •30 ml/min/1.73m^2 20. Active systemic infection 21. Active malignancy within
- •the last 5 years 22. Not potential candidates for surgery or general anesthesia
- •23. Active illicit substance abuse or alcoholism 24. Pregnancy or wish getting
- •pregnant in next year 25. Participating in another ongoing clinical trial of an
- •investigational drug or device that can interfere with the current study 26.
- •Any other mental or physical condition which, in the opinion of the
- •investigator, makes the subject a poor candidate for clinical trial
- •participation
研究者
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