Cardio-vascular Disease, Hypogonadism, Metabolic Syndrome
Conditions
Keywords
Testicular Neoplasms, Hypogonadism, Metabolic Syndrome, Treatment related late effects
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.
Interventions
None listed
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density (Gram/cm2) | Up to 12 months | Bone mineral density assessed by DXA-scan |
| Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide | Up to 12 months | — |
| Renal function (Glomerular Filtration Rate ml/min) | Up to 12 months | Renal function is assessed with 51Cr-EDTA |
| Fasting Blood Glucose | Up to 12 months | — |
| plasma-insulin | Up to 12 months | — |
| Lean body mass (Kilogram) | Up to 12 months | Lean body mass assessed by DXA-scan |
| Ultrasonic appearance and size of the remaining testicle | Up to 12 months | Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound |
| Quality of life | Up to 12 months | Quality of Life is assessed by the EORTC QLQ-30 Questionnaire |
| Anxiety and depression | Up to 12 months | Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS) |
| Fatigue | Up to 12 months | Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20) |
| Adiponectin and leptin | Up to 12 months | — |
Countries
Denmark
Outcome results
None listed