NL-OMON21610尚未招募不适用
Endoscopic application of pulsed electric fields by the DyaMX 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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
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
入选标准
- •1.Diagnosed with type 2 diabetes mellitus
- •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.No specific restrictions regarding concomitant other glucose lowering drugs
- •6.BMI = 24 and = 40 kg/m2
- •7.HbA1c = 8.0% (64 mmol/mol)
- •8.Fasting C-peptide = 0.5 nmol/L (1.5 ng/ml)
- •9.Fasting Plasma Glucose = 10 mmol/L
- •10.Willing to comply with study requirements and able to understand and comply with informed consent
- •11.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.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
- •4.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
- •5.History of chronic or acute pancreatitis
- •6.Known active hepatitis or active liver disease
- •7.Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn’s Disease and Celiac Disease
- •8.History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
- •9.Use of anticoagulation therapy (such as phenprocoumon and acenocoumarol) and novel oral anticoagulants (such as rivaroxaban, apixaban, edoxaban and dabigatran) which cannot be discontinued for 7 days before and 14 days after the procedure
- •10.Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
- •11.Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
- •12.Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
- •13.Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
- •14.Persistent Anemia, defined as Hgb < 6.2 mmol/l
- •15.Known history of cardiac arrythmia
- •16.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
- •17.With any implanted electronic devices or duodenal metallic implants
- •18.eGFR or MDRD < 30 ml/min/1.73m^2
- •19.Active systemic infection
- •20.Active malignancy within the last 5 years
- •21.Not potential candidates for surgery or general anesthesia
- •22.Active illicit substance abuse or alcoholism
- •23.Pregnancy or wish getting pregnant in next year
- •24.Participating in another ongoing clinical trial of an investigational drug or device
- •25.Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
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