Hypogonadotropic HypogonadismNCT02062307
Bone Mineral Markers in Hypogonadism
An observational study of Hypogonadotropic Hypogonadism and Endothelial Dysfunction, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadotropic Hypogonadism, Endothelial Dysfunction, Insulin Resistance
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2012to Aug 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study group was selected from the male subjects with hypogonadotropic hypogonadism who were not previously given testosterone or human chorionic gonadotropin therapy. The patients did not have any chronic metabolic disorders or organ dysfunction. Forty three age and BMI matched male volunteers were enrolled as control subjects.
Who may be able to join
- male patients with hypogonadotropic hypogonadism
- being under the age of 45 and over the age of 18
- not previously given testosterone or human chorionic gonadotropin therapy
- not have any chronic metabolic disorders or organ dysfunction
Who cannot join
- female patients
- Other reasons hipogondism
- receive any treatment of hypogonadism
- presence of comorbid diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism
The aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance.
Read the detailed description
Cardiometabolic disorders are prevalent in patients with hypogonadism. Endothelial dysfunction and insulin resistance are used in determining cardiovascular risk. The role of markers of bone mineral metabolism in hypogonadism is not clearly presented.
49 male patients with hypogonadotropic hypogonadism (HH) and 43 BMI and age matched healthy male subjects were enrolled. Osteoprotegerin (OPG), fibroblast growth factor-23 (FGF-23), vitamin D and asymmetric dimethylarginine (ADMA) levels were measured. The insulin sensitivity was estimated by homeostatic model assessment-insulin resistance (HOMA-IR) formula.
- Keywords
- Hypogonadism, Asymmetric Dimethyl Arginine, Osteoprotegerin, Fibroblast Growth Factor, Vitamin D
- Medical subject headings
- Hypogonadism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control patients | BMI and age matched healthy male subjects | |
| hypogonadism patients | unconfounded group of patients with hypogonadism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels
investigate the markers of bone mineral metabolism in patients with hypogonadism
Measured: one year
Secondary outcomes (1)
relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coskun Meric, Gulhane School of Medicine
- Investigators
- Coskun Meric, Principal investigator, Gulhane School of Medicine Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062307
- Sponsor's protocol ID
- cmeric2000
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism
- ClinicalTrials.gov ID
- NCT02062307
- Acronym / sponsor ID
- cmeric2000
- Keywords
- Hypogonadism, Asymmetric Dimethyl Arginine, Osteoprotegerin, Fibroblast Growth Factor, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Feb 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 aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance.
Detailed description
Cardiometabolic disorders are prevalent in patients with hypogonadism. Endothelial dysfunction and insulin resistance are used in determining cardiovascular risk. The role of markers of bone mineral metabolism in hypogonadism is not clearly presented.
49 male patients with hypogonadotropic hypogonadism (HH) and 43 BMI and age matched healthy male subjects were enrolled. Osteoprotegerin (OPG), fibroblast growth factor-23 (FGF-23), vitamin D and asymmetric dimethylarginine (ADMA) levels were measured. The insulin sensitivity was estimated by homeostatic model assessment-insulin resistance (HOMA-IR) formula.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control patients | – | –BMI and age matched healthy male subjects |
| hypogonadism patients | – | –unconfounded group of patients with hypogonadism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group was selected from the male subjects with hypogonadotropic hypogonadism who were not previously given testosterone or human chorionic gonadotropin therapy. The patients did not have any chronic metabolic disorders or organ dysfunction. Forty three age and BMI matched male volunteers were enrolled as control subjects.
Key inclusion criteria (4 listed)
- male patients with hypogonadotropic hypogonadism
- being under the age of 45 and over the age of 18
- not previously given testosterone or human chorionic gonadotropin therapy
- not have any chronic metabolic disorders or organ dysfunction
Key exclusion criteria (4 listed)
- female patients
- Other reasons hipogondism
- receive any treatment of hypogonadism
- presence of comorbid diseases
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
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels
Time frame: one year
investigate the markers of bone mineral metabolism in patients with hypogonadism
1 secondary outcome
relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance
Time frame: one year
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 13 Feb 2014.
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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.
Coskun Meric principal investigator
Gulhane School of Medicine Department of Endocrinology
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 Hypogonadotropic Hypogonadism and Endothelial Dysfunction, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 13 Feb 2014. 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 Turkey (Türkiye). 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?
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2014.