NCT02079376Unknown不适用
The DIAMOND® for the Treatment of Type 2 Diabetes: Can Blood Triglycerides Level be the Predictor for Therapy Efficiency A Multicentre, Prospective, Semi-randomized Study
MetaCure Limited13 个研究点 分布在 6 个国家目标入组 45 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 13
- 主要终点
- improvement of HbA1c
研究概览
简要总结
Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c.
Relationship between blood TG level and the GCM efficacy will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 through 70 years of age
- •Body mass index > 30 and < 45 (kg/m2)
- •Type 2 diabetes duration of at least 6 months
- •Type 2 diabetic subjects treated with oral anti-diabetic agents [Sulfonylurea, Metformin, thiazolinedione (TZD) or DPP-4 inhibitors]
- •Stable anti-diabetic medications for at least 3 months prior to enrollment, six months for thiazolinedione (TZD)
- •The subject has been under routine diabetes care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
- •HbA1c 7.3% and ≤ 9.5 % on Visit 1
- •Stable HbA1c, defined as no significant change (variation ≤ 0.5%) between a historical value recorded in the subject's medical record within 3 months prior to enrollment and the HbA1c gathered on Visit
- •Fasting blood glucose >120 and < 350 mg/dl on Visit
- •Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
- •Stable weight, defined as no significant weight change (variation <3%) within three months prior to enrollment as documented in the subject's medical record. For the subject treated with thiazolinedione, stable weight within six months.
- •If taking theses medication, sable anti-hypertensive and lipid-lowering medication for at least one month prior to enrollment
- •If subject is under anti-depressant medication the treatment needs to be stable for at least six months prior to enrollment.
- •Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the DIAMOND System
- •Willingness to perform at least four (3) capillary blood glucose tests per day twice a week for the duration of the study
- •Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
- •Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
- •Able to provide voluntary informed consent
排除标准
- •Insulin therapy in last 3 months
- •Taking GLP-1 agonists or in the last 3 months before the enrollment
- •Currently taking fibrates, nicotinamide and omega 3 fatty acids as antilipidemic treatment
- •Subjects with an EF less than 35% or otherwise indicated for an ICD
- •Taking medications known to affect gastric motility such as narcotics (chronic use) and anticholinergics/antispasmodics
- •Experiencing severe and progressing diabetic complications (i.e. retinopathy not stabilized, nephropathy with macroalbuminuria)
- •Prior wound healing problems due to staphylococcus or candida
- •Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures
- •Use of anti-psychotic medications
- •Diagnosed with a eating disorder such as bulimia or binge eating
- •Obesity due to an endocrine disorder (e.g. Cushing disease)
- •Pregnant or lactating
- •Diagnosed with impaired liver function (liver enzymes 3 times greater than normal)
- •Any prior bariatric surgery
- •Any history of pancreatitis
- •Any history of peptic ulcer disease within 5 years of enrollment
- •Diagnosed with gastroparesis
- •Use of active medical devices (either implantable or external) such as ICD, pacemaker, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.
- •Cardiac history that physician feels should exclude the subject from the study.
- •Use of another investigator device or agent in the 30 days prior to enrollment
- •A history of life-threatening disease within 5 years of enrollment
- •Change in diabetic medication from between Visit 1 and Visit
- •Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study
结局指标
主要结局
improvement of HbA1c
时间窗: 48 weeks
improvement of glycemic control measured by changes in HbA1c
次要结局
- Relationship between blood TG level and the GCM efficacy(48 weeks)
研究者
研究点 (13)
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