Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria
研究概览
简要总结
The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.
详细描述
Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients with low levels of testosterone appear to be at higher risk of metabolic syndrome.
A substantial number of testicular cancer survivors might be in a state of "compensated hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive from the pituitary gland.
Whether this specific groups of testicular cancer survivors are at increased risk of cardio-vascular disease and might benefit from testosterone substitution is yet to be clarified.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Earlier treatment of testicular germ cell cancer
- •No sign of relapse > 1 year since latest treatment
- •Testosterone < 12 nmol/L and luteinizing hormone > 8 IE/L OR
- •Testosterone > 12 nmol/L and LH > 8 IE/L OR
- •Testosterone and LH within their normal ranges
排除标准
- •Testosterone substitution
结局指标
主要结局
Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria
时间窗: Up to 12 months
次要结局
- Bone Mineral Density (Gram/cm2)(Up to 12 months)
- Lean body mass (Kilogram)(Up to 12 months)
- Renal function (Glomerular Filtration Rate ml/min)(Up to 12 months)
- Ultrasonic appearance and size of the remaining testicle(Up to 12 months)
- Anxiety and depression(Up to 12 months)
- Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide(Up to 12 months)
- Fasting Blood Glucose(Up to 12 months)
- Adiponectin and leptin(Up to 12 months)
- Quality of life(Up to 12 months)
- Fatigue(Up to 12 months)
- plasma-insulin(Up to 12 months)
研究者
Mikkel Bandak
MD
Rigshospitalet, Denmark