NCT02413567已完成不适用
Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
研究概览
简要总结
The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.
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
- 28 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •28 -75 years of age
- •Diagnosed with Type 2 Diabetes for less than 10 years
- •HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
- •Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
- •On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry
- •Willing to comply with study requirements and able to understand and comply with informed consent
- •Sign an informed consent form
排除标准
- •Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
- •Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l)
- •Current use of Insulin
- •Use of Glucagon like peptide (GLP)-1 analogues
- •Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
- •Known autoimmune disease, as evidenced by a positive anti glutamic acid decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Previous gastrointestinal (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
- •History of chronic or acute pancreatitis
- •Known active hepatitis or active liver disease
- •Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
- •History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
- •Use of anticoagulation therapy (such as Warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
- •Use of P2Y12 inhibitors (clopidrogel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
- •Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
- •Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
- •Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
- •Persistent Anemia, defined as Hgb < 10 mg/dl
- •Estimated glomerular filtration rate (eGFR) or Modification of Diet in Renal Disease (MDRD) <30 ml/min/1,73m^2
- •Active systemic infection
- •Active malignancy within the last 5 years
- •Not potential candidates for surgery or general anesthesia
- •Active illicit substance abuse or alcoholism
- •Those who are pregnant, nursing or expect to become pregnant over the course of the study
- •Participating in another ongoing clinical trial
- •Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation
研究组 & 干预措施
DMR Procedure
Experimental
Subjects receive the endoscopic DMR procedure in this arm
干预措施: DMR Procedure (Fractyl) (Device)
结局指标
主要结局
mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure
时间窗: 24 weeks post-procedure
Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)
时间窗: 24 weeks post-procedure
次要结局
未报告次要终点
研究者
研究点 (7)
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