Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose Lowering Action in Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
研究概览
简要总结
The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type II diabetes, for at least one year prior to randomization
- •Body mass index BMI < 35 Kg/m2
- •Stable glucose lowering drugs regimen for at least one month prior to randomization
- •Capable of giving informed consent
排除标准
- •Pregnancy, or nursing
- •10< HbA1c < 6
- •Permanent pacemakers
- •Metal prosthesis
- •Resting blood pressure > 160/ 100 mmHg
- •Skin disease
- •Treatment with steroids or beta-blockers treatment with psychiatric medications
研究组 & 干预措施
PES Treatment
Eligible patients will receive daily 5 min PES treatment for two weeks. Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) continuous glucose monitor (CGM) System
干预措施: Stimulator (Device)
Control
Interstitial glucose will be monitored throughout the study using a FreeStyle Navigator (Abbott Diabetes Care, Alameda, CA) CGM System
结局指标
主要结局
Number of participants with hypoglycemia, and/ or adverse events that are related to treatment
时间窗: Baseline through 2 months
次要结局
- Incidence of minor side effects related to treatment(Baseline through 2 months)
- Changes in mean interstitial glucose levels measured by CGM(Baseline, 1, 2, 5, and 6 weeks)