NL-OMON54013招募中不适用
Endoscopic application of pulsed electric fields by the Endogenex system® for duodenal Mucosal regeneration for elimination of INsulin in the treatmENT of type 2 diabetes: a first in human safety, feasibility and efficacy study - EMINENT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
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 64（—）
入选标准
- •1. Diagnosed with Type 2 Diabetes
- •2. 28 -75 years of age
- •3. Treatment with long acting insulin <= 10 years
- •4. On daily long acting insulin dose <= 1 U/kg
- •5. BMI >= 24 and <= 40 kg/m2
- •6. HbA1c <= 8.0% (64 mmol/mol)
- •7. Fasting C-peptide >= 0.2 nmol/L (0.6 ng/ml)
- •8. Willing to comply with study requirements and able to understand and comply
- •with informed consent
- •9. Signed informed consent form
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 GLP-1 analogue.
- •4. A positive Anti-GAD test, as an indication of type 1 diabetes mellitus or
- •Latent Autoimmune Diabetes of the Adult (LADA) with progressive beta-cell loss.
- •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
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