NCT02564627已完成3 期
Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 With an Ambulatory Self-applied Patch vs PENS of Dermatome T6 With Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients
Abdel Kadar Clinic0 个研究点目标入组 90 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Appetite will be quantified with a visual analogic scale
研究概览
简要总结
A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups:
- PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet
- PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet
- Only 1200Kcal/day diet
The effect on appetite and weight loss will be investigated.
详细描述
A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups:
- PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet
- PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet
- Only 1200Kcal/day diet
The effect on appetite and weight loss will be investigated.
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
- None
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
- •Moderately obese patients (BMI 30-39 kg/m2)
排除标准
- •Endocrinological diseases causing obesity
- •Heart pacemaker
- •Previous bariatric procedure
结局指标
主要结局
Appetite will be quantified with a visual analogic scale
时间窗: 12 weeks
Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite)
次要结局
- Weight loss(12 weeks)
- Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist(12 weeks)
研究者
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