Metabolic Syndrome Clinical Trial
Official title:
Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Verified date | July 2016 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Observational |
The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.
Status | Completed |
Enrollment | 200 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Lean body mass (Kilogram) | Lean body mass assessed by DXA-scan | Up to 12 months | No |
Secondary | Bone Mineral Density (Gram/cm2) | Bone mineral density assessed by DXA-scan | Up to 12 months | No |
Secondary | Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide | Up to 12 months | No | |
Secondary | Renal function (Glomerular Filtration Rate ml/min) | Renal function is assessed with 51Cr-EDTA | Up to 12 months | No |
Secondary | Fasting Blood Glucose | Up to 12 months | No | |
Secondary | plasma-insulin | Up to 12 months | No | |
Secondary | Adiponectin and leptin | Up to 12 months | No | |
Secondary | Ultrasonic appearance and size of the remaining testicle | Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound | Up to 12 months | No |
Secondary | Quality of life | Quality of Life is assessed by the EORTC QLQ-30 Questionnaire | Up to 12 months | No |
Secondary | Anxiety and depression | Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS) | Up to 12 months | No |
Secondary | Fatigue | Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20) | Up to 12 months | No |
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