NCT01927562已完成不适用
Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Changed in Mixed Meal Tolerance From Baseline to 3 Months
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.
详细描述
The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System and its effect on participants with Type 2 Diabetes. This will be determined through the monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).
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
- •Participants Age > 28 years and ≤ 75 years
- •Male or Female
- •Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
- •Participants with an HbA1c > 7.5 and ≤ 10.0%
- •Participants with a BMI > 24 and < 40
- •Participants willing to comply with study requirements and able to understand and comply with informed consent
- •Participants who have signed an informed consent form
排除标准
- •Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
- •Participants using insulin for more than 12 months
- •Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
- •Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
- •Participants requiring prescription anticoagulation therapy and/or dual anti-platelet therapy including aspirin who cannot discontinue their medication for 14 days before and 14 days after the procedure
- •Participants with iron deficiency anemia - either currently or in their history
- •Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
- •Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
- •Participants with symptomatic gallstones or kidney stones at the time of screening
- •Participants with a history of pancreatitis
- •Participants with an active systemic infection
- •Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
- •Participants with celiac disease
- •Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
- •Participants with known active hepatitis or active liver disease
- •Participants emotionally unstable or who exhibit psychological characteristics which, in the opinion of the Investigator, make the participant a poor candidate for clinical trial participation
- •Participants with previous GI surgery that could affect the ability to treat the duodenum such as participants who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
- •Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
- •Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
- •Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
- •Participants with active illicit substance abuse or alcoholism
- •Participants participating in another ongoing investigational clinical trial
- •Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
- •Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia
结局指标
主要结局
Changed in Mixed Meal Tolerance From Baseline to 3 Months
时间窗: 3 months
Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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