Metabolic SyndromeNCT02240966
Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
An observational study of Metabolic Syndrome and Hypogonadism, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Hypogonadism, Cardio-vascular Disease
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Testicular cancer survivors
Who may be able to join
- 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
Who cannot join
- Testosterone substitution
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.
Read the 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.
- Conditions
- Metabolic Syndrome, Hypogonadism, Cardio-vascular Disease
- Keywords
- Testicular Neoplasms, Hypogonadism, Metabolic Syndrome, Treatment related late effects
- Medical subject headings
- Metabolic Syndrome, Hypogonadism, Testicular Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Secondary outcomes (11)
Lean body mass (Kilogram)
Lean body mass assessed by DXA-scan
Measured: Up to 12 months
Bone Mineral Density (Gram/cm2)
Bone mineral density assessed by DXA-scan
Measured: Up to 12 months
Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide
Measured: Up to 12 months
Renal function (Glomerular Filtration Rate ml/min)
Renal function is assessed with 51Cr-EDTA
Measured: Up to 12 months
Fasting Blood Glucose
Measured: Up to 12 months
plasma-insulin
Measured: Up to 12 months
Adiponectin and leptin
Measured: Up to 12 months
Ultrasonic appearance and size of the remaining testicle
Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound
Measured: Up to 12 months
Quality of life
Quality of Life is assessed by the EORTC QLQ-30 Questionnaire
Measured: Up to 12 months
Anxiety and depression
Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS)
Measured: Up to 12 months
Fatigue
Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Bandak, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gedske Daugaard, DMSc, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240966
- Sponsor's protocol ID
- H-3-2013-1 75
- Status last verified
- Jul 2016
- First submitted
- 8 Sep 2014
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bandak M, Jorgensen N, Juul A, Lauritsen J, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Leydig cell dysfunction, systemic inflammation and metabolic syndrome in long-term testicular cancer survivors. Eur J Cancer. 2017 Oct;84:9-17. doi: 10.1016/j.ejca.2017.07.006. Epub 2017 Jul 31.
PubMed 28772110Bandak M, Jorgensen N, Juul A, Lauritsen J, Kier MGG, Mortensen MS, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers. Andrology. 2017 Jul;5(4):718-724. doi: 10.1111/andr.12355. Epub 2017 Jun 9.
PubMed 28598554
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
- ClinicalTrials.gov ID
- NCT02240966
- Acronym / sponsor ID
- H-3-2013-1 75
- Conditions
- Metabolic Syndrome, Hypogonadism, Cardio-vascular Disease
- Keywords
- Testicular Neoplasms, Hypogonadism, Metabolic Syndrome, Treatment related late effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Testicular cancer survivors
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Testosterone substitution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Lean body mass (Kilogram)
Time frame: Up to 12 months
Bone Mineral Density (Gram/cm2)
Time frame: Up to 12 months
Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide
Time frame: Up to 12 months
Renal function (Glomerular Filtration Rate ml/min)
Time frame: Up to 12 months
Fasting Blood Glucose
Time frame: Up to 12 months
plasma-insulin
Time frame: Up to 12 months
Adiponectin and leptin
Time frame: Up to 12 months
Ultrasonic appearance and size of the remaining testicle
Time frame: Up to 12 months
Quality of life
Time frame: Up to 12 months
Anxiety and depression
Time frame: Up to 12 months
Fatigue
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 28772110Bandak M, Jorgensen N, Juul A, Lauritsen J, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Leydig cell dysfunction, systemic inflammation and metabolic syndrome in long-term testicular cancer survivors. Eur J Cancer. 2017 Oct;84:9-17. doi: 10.1016/j.ejca.2017.07.006. Epub 2017 Jul 31.
- Derived from this study: PubMed 28598554Bandak M, Jorgensen N, Juul A, Lauritsen J, Kier MGG, Mortensen MS, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers. Andrology. 2017 Jul;5(4):718-724. doi: 10.1111/andr.12355. Epub 2017 Jun 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gedske Daugaard, DMSc study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Hypogonadism, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02240966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.