NCT00863954已完成1 期
A Controlled Pilot Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in blood glucose and A1c levels at endpoint compared to start
研究概览
简要总结
The purpose of this study is to see if using a device called the Resonator, that puts out a very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2 Diabetes.
详细描述
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant reductions in finger stick blood glucose levels, serum glucose and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids and liver function tests as indirect markers of insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of Type II Diabetes Mellitus with A1c level above the upper limit of normal
- •Subject currently performs routine finger stick blood sugar testing
- •Subject is ambulatory
- •None or stable medication regimen without significant side effects for at least 6 months, willingness and ability to maintain the stable medication regimen throughout the course of the study.
- •Hemoglobin A1c levels within a 0.8% range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
- •Willingness to test finger stick blood sugars according to protocol.
- •Willingness to have lab test blood draws performed according to protocol
- •Willingness to maintain stable diet and activity regimen for the duration of the study.
- •Willing and able to abstain from partaking in any non-essential existing or new treatments to improve serum blood sugar levels.
- •Adequate contraceptive measures for female subjects
- •Male or female
- •Any ethnic group
- •Between 21 and 80 years of age
排除标准
- •Change in medical regimen within 6 months prior to initiation of study
- •Any signs of Type I diabetes
- •Active infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level.
- •Change in BMI of greater than 6% within a 6 month period prior to study initiation
- •Any planned revascularization procedure
- •Symptomatic congestive heart failure
- •Leg or foot ulceration or open wounds
- •History of intermittent claudication
- •Hemodialysis
- •Currently being treated for malignancy
- •Currently being treated with oral or intravenous catabolic steroids.
- •Reported consumption of more than 14 alcoholic drinks per week.
- •Pregnant, breast feeding,or planning pregnancy prior to the end of participation.
- •Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
- •Uncontrolled hypertension
- •Uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia
- •Uncontrolled seizure disorder
- •Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subjects health or ability to complete the entire study, in the opinion of the investigator
结局指标
主要结局
Reduction in blood glucose and A1c levels at endpoint compared to start
时间窗: Start point, 3 months and 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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