NCT02659371已完成不适用
Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study
Copenhagen University Hospital at Herlev2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.
The study is a pilot study with a diet intervention group and no control group. The intervention is a 12 week low energy diet pre-operative weight loss program investigating if this will result in weight loss making the overweight and obese patients eligible for breast reduction surgery i.e. BMI < 25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •entitled to mammoplasty,
- •motivated towards participation in a weight loss program
- •BMI within the range 25.5 to 35 kg/m2
排除标准
- •more than 65 years of age
- •insulin-dependent diabetes
- •chronic heart, liver or kidney failure
结局指标
主要结局
Weight loss
时间窗: 12 weeks
Measurement of weight to nearest 0.1 kg on category III approved body weight
次要结局
- Breast size(12 weeks)
- Pain and discomfort(12 weeks)
- Breast volumen(12 weeks)
研究者
Christian Bitz
Head of research
Copenhagen University Hospital at Herlev
研究点 (2)
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