Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

Metabolic Syndrome Clinical Trial

Official title:

Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240966
• Other study ID #: H-3-2013-1 75
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: July 13, 2016
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardio-vascular Disease
• Cardiovascular Diseases
• Hypogonadism
• Metabolic Syndrome
• Metabolic Syndrome X
• Testicular Neoplasms
• Vascular Diseases

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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