Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.
Detailed Description
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.
Investigators
Mikkel Bandak
MD
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Testosterone substitution
Outcomes
Primary Outcomes
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
Time Frame: Up to 12 months
Secondary Outcomes
- 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)