NCT02122874已完成3 期
Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients
Hospital General Universitario Elche1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum glucose levels (mg/dl)
研究概览
简要总结
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>30 Kg/m2
- •Type 2 diabetes mellitus
- •Treatment with Metformin
排除标准
- •Under insulin treatment
- •Endocrinological disorders causing diabetes mellitus
研究组 & 干预措施
Diet
Active Comparator
The patients follow only a 1200 Kcal diet
干预措施: Percutaneous Neurostimulation (PENS) of dermatome T7 (Device)
Diet
Active Comparator
The patients follow only a 1200 Kcal diet
干预措施: 1200 Kcal diet (Other)
Diet +PENS dermatome T7
Experimental
The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
干预措施: Percutaneous Neurostimulation (PENS) of dermatome T7 (Device)
结局指标
主要结局
Serum glucose levels (mg/dl)
时间窗: Baseline and 12 weeks after beginning the therapy
Serum glucose levels will be recorded will be recorded at baseline and 12 weeks after beginning the treatment. Measurement units will be mg/dl.
次要结局
- Homeostasis model assessment (HOMA)(Baseline and 12 weeks after beginning the therapy)
研究者
Jaime Ruiz-Tovar, MD, PhD
MD, PhD
Hospital General Universitario Elche
研究点 (1)
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