NCT03977064招募中不适用
Fertility and Cardiovascular Risk in Men With Metabolic Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism
研究概览
简要总结
Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will receive pseudonymous data
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age>18 years, wish for fatherhood in stable partnership, metabolic syndrome according to guidelines (minimum 3 out of 5 criteria), ready to participate in 1-yr lifestyle program
排除标准
- •Not conforming to MetS diagnosis criteria, sterilisation, promiscuous behaviour, contraindications against established medical or surgical treatment of obesity, participation in another weight-loss program
结局指标
主要结局
Number of participants with normalisation of diabetes or cardiovascular risk or improvement of hypogonadism
时间窗: 1 year
Diabetes risk Glycated hemoglobin \>5.7%, Cardiovascular risk score \>5%, Hypogonadism score increase of 20 points
次要结局
未报告次要终点
研究者
研究点 (1)
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