Hypogonadism, MaleMMetdMHNCT05773183
Exploring the Relationship Between Androgen Metabolism, Metabolic Disease and Skeletal Muscle Energy Balance in Men
An observational study of Hypogonadism, Male and Testosterone Deficiency, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
This study relates to men with hypogonadism, a condition describing a deficiency of androgens such as testosterone. Deficiency of these hormones occurs in men due to testicular (primary) or hypothalamic-pituitary (secondary) problems or may be observed in men undergoing androgen deprivation therapy for prostate… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Male, Testosterone Deficiency, Prostate Cancer
- What is being tested?
- Testosterone and GnRH
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- 12 Mar 2023to Aug 2024
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Observational Cohort 1 (OBS1): * 20 eugonadal healthy volunteer controls * 20 hypogonadal men pre initiation of testosterone replacement therapy Interventional Cohort 1 (IC1): • 20 hypogonadal men 6 months post initiation of testosterone replacement therapy Interventional Cohort 2 (IC2): • 20 men with prostate cancer pre and 3 months post initiation of GnRH analogue therapy
Who may be able to join
- Able to provide consent
- Ages 18 - 60 years
- BMI 20 - 35 kg / m2
- Able to provide consent
- Ages 40-85 years
- BMI 20 - 35 kg / m2
Who cannot join
- Contraindication to testosterone replacement for patients with hypogonadism
- BMI <20 or > 35 kg / m2
- Age < 18 or > 60 years
- Diabetes Mellitus
- Confirmed ischaemic heart disease
- In patients with secondary hypogonadism co-existence of any untreated pituitary hormone deficiencies (ACTH, TSH, GH deficiency)
Show all 14Show fewer
- Glucocorticoid use via any route within the last three months
- Current intake of drugs known to impact upon steroid or metabolic function or intake of such drugs during the six months preceding the planned recruitment
- Diabetes mellitus
- Confirmed ischaemic heart disease
- Any glucocorticoid therapy in the last 3 months (inhaled/transdermal/systemic)
- BMI <20 or >35
- Pre-existing hormonal pathology - primary testicular or pituitary pathology
- Age <40 or >85
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Beaumont Hospital
Dublin
Michael Professor O'Reilly, FRCPI PhD, 018093894, michaelworeilly@rcsi.ie
Clare Dr Miller, BM BS, +353857509379, claremiller22@rcsi.com
About this study
This study relates to men with hypogonadism, a condition describing a deficiency of androgens such as testosterone. Deficiency of these hormones occurs in men due to testicular (primary) or hypothalamic-pituitary (secondary) problems or may be observed in men undergoing androgen deprivation therapy for prostate cancer.
Testosterone plays an important role in male sexual development and health, but also plays a key role in metabolism and energy balance. Men with testosterone deficiency have higher rates of metabolic dysfunction. This results in conditions such as obesity, nonalcoholic fatty liver disease, diabetes, and cardiovascular disease. Studies have confirmed that treating testosterone deficiency with testosterone can reduce the risk of some of these adverse metabolic outcomes, however cardiovascular mortality remains higher than the general population. We know that testosterone deficiency therefore causes metabolic dysfunction. However, research to date has not established the precise mechanisms behind this.
Read more
In men with hypogonadism there is a loss of skeletal muscle bulk and function. Skeletal muscle is the site of many critical metabolic pathways; therefore it is likely that testosterone deficiency particularly impacts metabolic function at this site. Men with testosterone deficiency also have excess fat tissue, this can result in increased conversion of circulating hormones to a type of hormone which further suppresses production of testosterone. The mechanism of metabolic dysfunction in men with hypogonadism is therefore multifactorial.
The purpose of this study is to dissect the complex mechanisms linking obesity, androgens and metabolic function in men. Firstly, we will carry out a series of detailed metabolic studies in men with testosterone deficiency, compared to healthy age- and BMI-matched men. Secondly, we will perform repeat metabolic assessment of hypogonadal men 6 months after replacement of testosterone in order to understand the impact of androgen replacement on metabolism. Lastly, we will perform the same detailed metabolic assessment in men with prostate cancer before and after introduction of a drug which causes testosterone deficiency for therapeutic purposes.
Read the detailed description
Male hypogonadism occurs due to a deficiency of androgens such as testosterone due to either primary (testicular) or secondary (hypothalamic pituitary) pathology. The incidence of testosterone deficiency is likely to increase with more cancer survivors, opiate use, increased awareness and thus diagnosis of testosterone deficiency. Hypogonadism in males is an independent risk factor for the development of metabolic syndrome and is associated with increased prevalence of insulin resistance, type two diabetes, non-alcoholic fatty liver disease, visceral adiposity, and cardiovascular disease.
The relationship between hypogonadism and metabolic dysfunction is bidirectional with secondary hypogonadism documented in a large proportion of men with obesity without a testicular or central cause of androgen deficiency. A vicious cycle exists whereby increased adipose tissue in men with obesity results in depleting circulating testosterone stores due to increased aromatisation of testosterone to oestrogen and suppression of gonadotrophin mediated testosterone secretion via negative feedback. This perpetuates visceral adiposity in men with pre-existing metabolic dysfunction.
The hormonal impact of visceral adiposity plays a role in aggravating metabolic disease in men with hypogonadism however the initial metabolic perturbation causing obesity and metabolic disease in these men has not been established. It is probable skeletal muscle dysfunction is a major player. Skeletal muscle is the primary site for glucose uptake and utilisation and houses critical metabolic pathways such as oxidative phosphorylation in mitochondria. Men with hypogonadism experience loss of skeletal muscle bulk and function. Research has previously demonstrated that pathologic alterations in androgen exposure result in mitochondrial dysfunction in females. Studies have also confirmed improvements in mitochondrial function include increased phosphorylation of AMPKα in men with diabetes and hypogonadotropic hypogonadism and in animal models increased expression of genes related to mitochondrial respiration enzymes following introduction of testosterone(12). These findings hint at a pivotal role for androgens in mitochondrial function and energy biogenesis in skeletal muscle. However, to date no mechanistic study has established the precise cellular mechanisms adversely modified by androgen deficiency in males.
Induction of hypogonadism or medical castration is a well-established therapeutic goal in men with recurrent or metastatic hormonally driven prostate cancer. This is typically achieved with androgen deprivation therapy either a GnRH analogue or androgen receptor blockade. Over half of men receiving ADT for treatment of prostate cancer experience metabolic syndrome. These men represent an excellent biological model for studying the association between hypogonadism and metabolic syndrome however research to date has focused on establishing the association but not the responsible mechanisms.
This study will establish the mechanism of metabolic dysfunction in males with androgen deficiency. Firstly a cohort of men with hypogonadism prior to testosterone replacement will undergo detailed metabolic phenotyping using multiple approaches including metabolomic data from skeletal muscle samples, and metabolic parameters using serum samples. This data will be compared to age and weight matched eugonadal healthy controls before and after testosterone replacement as per routine clinical care. The same detailed metabolic phenotyping will be performed on men with prostate cancer before and after therapeutic induction of hypogonadism.
Our study will provide an unparalleled understanding of the tissue- and sex-specific role of androgens as a driver of metabolic dysfunction. Anticipated disturbances in mitochondrial function and energy biogenesis in androgen excess and deficiency will advance scientific knowledge and create potential for developing future tissue specific mediators of metabolic dysfunction in males with hypogonadism.
- Conditions
- Hypogonadism, Male, Testosterone Deficiency, Prostate Cancer, Androgen Deficiency, Metabolic Disease, Metabolic Syndrome
- Being tested
- Testosterone, GnRH
- Keywords
- mechanism, mechanistic study
- Medical subject headings
- Eunuchism, Prostatic Neoplasms, Metabolic Diseases, Metabolic Syndrome, Obesity, Cardiovascular Diseases, Non-alcoholic Fatty Liver Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
In OBS1 20 men will be started on Testosterone replacement therapy as per routine clinical practice. Data collection will occur prior initiating therapy, and 6 months post
GnRHDrug
Also called GnRH analogue
20 men in OBS2 planned for GnRH analogue therapy will undergo data collection prior, and 3 months post initiation of GnRH analogue therapy
| Study group | Role | What they receive |
|---|---|---|
| OBS1 [Observational Cohort 1] | 20 Eugonadal Healthy men 20 Men with Testosterone Deficiency not currently on Testosterone replacement therapy | |
| IC1 [Interventional Cohort 1] | 20 Men with Testosterone Deficiency progressed from OBS1 6 months post initiation of testosterone replacement therapy Receives: Drug: Testosterone | |
| IC2 [Interventional Cohort 2] | 20 men with prostate cancer planned for GnRH analogue therapy Receives: Drug: GnRH |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism compared to controls
Differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism compared to controls
Measured: 24 months
To compare differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism pre and post testosterone replacement
Differences in non-targeted serum and skeletal muscle metabolomics in men
Measured: 24 months
To compare differences in steroid metabolomics in men with prostate cancer pre- and post-androgen deprivation therapy (ADT)
Differences in steroid metabolomics in men with prostate cancer pre- and post-androgen deprivation therapy (ADT)
Measured: 24 months
Secondary outcomes (4)
To compare differences in steroid metabolomics in men with hypogonadism compared to controls
Differences in serum, urinary and salivary steroid metabolism
Measured: 24 months
To compare differences in steroid metabolomics in men with hypogonadism pre and post testosterone replacement
Differences in serum, urinary and salivary steroid metabolism
Measured: 24 months
To compare differences in steroid metabolomics in men with prostate cancer pre- and post-androgen deprivation therapy
Differences in serum, urinary and salivary steroid metabolism
Measured: 24 months
To compare differences in metabolic phenotype in (i) hypogonadal men compared to healthy men (ii) hypogonadal men pre and post testosterone replacement therapy (iii) men with prostate cancer post initiation of Androgen Deprivation Therapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start12 Mar 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Steroid Metabolism Analysis Core, University of Birmingham, University of Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773183
- Sponsor's protocol ID
- MMetDMH
- Acronym
- MMetdMH
- Status last verified
- Dec 2022
- First submitted
- 6 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Androgen Metabolism, Metabolic Disease and Skeletal Muscle Energy Balance in Men
- ClinicalTrials.gov ID
- NCT05773183
- Acronym / sponsor ID
- MMetdMH / MMetDMH
- Conditions
- Hypogonadism, Male, Testosterone Deficiency, Prostate Cancer, Androgen Deficiency, Metabolic Disease, Metabolic Syndrome
- Keywords
- mechanism, mechanistic study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Steroid Metabolism Analysis Core, University of Birmingham, University of Liverpool
- Study start
- 12 Mar 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 17 Mar 2023 (actual)
- 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.
This study relates to men with hypogonadism, a condition describing a deficiency of androgens such as testosterone. Deficiency of these hormones occurs in men due to testicular (primary) or hypothalamic-pituitary (secondary) problems or may be observed in men undergoing androgen deprivation therapy for prostate cancer.
Testosterone plays an important role in male sexual development and health, but also plays a key role in metabolism and energy balance. Men with testosterone deficiency have higher rates of metabolic dysfunction. This results in conditions such as obesity, nonalcoholic fatty liver disease, diabetes, and cardiovascular disease. Studies have confirmed that treating testosterone deficiency with testosterone can reduce the risk of some of these adverse metabolic outcomes, however cardiovascular mortality remains higher than the general population. We know that testosterone deficiency therefore causes metabolic dysfunction. However, research to date has not established the precise mechanisms behind this.
In men with hypogonadism there is a loss of skeletal muscle bulk and function. Skeletal muscle is the site of many critical metabolic pathways; therefore it is likely that testosterone deficiency particularly impacts metabolic function at this site. Men with testosterone deficiency also have excess fat tissue, this can result in increased conversion of circulating hormones to a type of hormone which further suppresses production of testosterone. The mechanism of metabolic dysfunction in men with hypogonadism is therefore multifactorial.
The purpose of this study is to dissect the complex mechanisms linking obesity, androgens and metabolic function in men. Firstly, we will carry out a series of detailed metabolic studies in men with testosterone deficiency, compared to healthy age- and BMI-matched men. Secondly, we will perform repeat metabolic assessment of hypogonadal men 6 months after replacement of testosterone in order to understand the impact of androgen replacement on metabolism. Lastly, we will perform the same detailed metabolic assessment in men with prostate cancer before and after introduction of a drug which causes testosterone deficiency for therapeutic purposes.
Detailed description
Male hypogonadism occurs due to a deficiency of androgens such as testosterone due to either primary (testicular) or secondary (hypothalamic pituitary) pathology. The incidence of testosterone deficiency is likely to increase with more cancer survivors, opiate use, increased awareness and thus diagnosis of testosterone deficiency. Hypogonadism in males is an independent risk factor for the development of metabolic syndrome and is associated with increased prevalence of insulin resistance, type two diabetes, non-alcoholic fatty liver disease, visceral adiposity, and cardiovascular disease.
The relationship between hypogonadism and metabolic dysfunction is bidirectional with secondary hypogonadism documented in a large proportion of men with obesity without a testicular or central cause of androgen deficiency. A vicious cycle exists whereby increased adipose tissue in men with obesity results in depleting circulating testosterone stores due to increased aromatisation of testosterone to oestrogen and suppression of gonadotrophin mediated testosterone secretion via negative feedback. This perpetuates visceral adiposity in men with pre-existing metabolic dysfunction.
The hormonal impact of visceral adiposity plays a role in aggravating metabolic disease in men with hypogonadism however the initial metabolic perturbation causing obesity and metabolic disease in these men has not been established. It is probable skeletal muscle dysfunction is a major player. Skeletal muscle is the primary site for glucose uptake and utilisation and houses critical metabolic pathways such as oxidative phosphorylation in mitochondria. Men with hypogonadism experience loss of skeletal muscle bulk and function. Research has previously demonstrated that pathologic alterations in androgen exposure result in mitochondrial dysfunction in females. Studies have also confirmed improvements in mitochondrial function include increased phosphorylation of AMPKα in men with diabetes and hypogonadotropic hypogonadism and in animal models increased expression of genes related to mitochondrial respiration enzymes following introduction of testosterone(12). These findings hint at a pivotal role for androgens in mitochondrial function and energy biogenesis in skeletal muscle. However, to date no mechanistic study has established the precise cellular mechanisms adversely modified by androgen deficiency in males.
Induction of hypogonadism or medical castration is a well-established therapeutic goal in men with recurrent or metastatic hormonally driven prostate cancer. This is typically achieved with androgen deprivation therapy either a GnRH analogue or androgen receptor blockade. Over half of men receiving ADT for treatment of prostate cancer experience metabolic syndrome. These men represent an excellent biological model for studying the association between hypogonadism and metabolic syndrome however research to date has focused on establishing the association but not the responsible mechanisms.
This study will establish the mechanism of metabolic dysfunction in males with androgen deficiency. Firstly a cohort of men with hypogonadism prior to testosterone replacement will undergo detailed metabolic phenotyping using multiple approaches including metabolomic data from skeletal muscle samples, and metabolic parameters using serum samples. This data will be compared to age and weight matched eugonadal healthy controls before and after testosterone replacement as per routine clinical care. The same detailed metabolic phenotyping will be performed on men with prostate cancer before and after therapeutic induction of hypogonadism.
Our study will provide an unparalleled understanding of the tissue- and sex-specific role of androgens as a driver of metabolic dysfunction. Anticipated disturbances in mitochondrial function and energy biogenesis in androgen excess and deficiency will advance scientific knowledge and create potential for developing future tissue specific mediators of metabolic dysfunction in males with hypogonadism.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OBS1 [Observational Cohort 1] | – | –20 Eugonadal Healthy men 20 Men with Testosterone Deficiency not currently on Testosterone replacement therapy |
| IC1 [Interventional Cohort 1] | – | Drug: Testosterone20 Men with Testosterone Deficiency progressed from OBS1 6 months post initiation of testosterone replacement therapy |
| IC2 [Interventional Cohort 2] | – | Drug: GnRH20 men with prostate cancer planned for GnRH analogue therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Observational Cohort 1 (OBS1): * 20 eugonadal healthy volunteer controls * 20 hypogonadal men pre initiation of testosterone replacement therapy Interventional Cohort 1 (IC1): • 20 hypogonadal men 6 months post initiation of testosterone replacement therapy Interventional Cohort 2 (IC2): • 20 men with prostate cancer pre and 3 months post initiation of GnRH analogue therapy
Key inclusion criteria (6 listed)
- Able to provide consent
- Ages 18 - 60 years
- BMI 20 - 35 kg / m2
- Able to provide consent
- Ages 40-85 years
Key exclusion criteria (14 listed)
- Contraindication to testosterone replacement for patients with hypogonadism
- BMI <20 or > 35 kg / m2
- Age < 18 or > 60 years
- Diabetes Mellitus
- Confirmed ischaemic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneIn OBS1 20 men will be started on Testosterone replacement therapy as per routine clinical practice. Data collection will occur prior initiating therapy, and 6 months post | Drug | IC1 [Interventional Cohort 1] |
| GnRHAlso: GnRH analogue20 men in OBS2 planned for GnRH analogue therapy will undergo data collection prior, and 3 months post initiation of GnRH analogue therapy | Drug | IC2 [Interventional Cohort 2] |
Primary outcome
To compare differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism compared to controls
Time frame: 24 months
Differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism compared to controls
To compare differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism pre and post testosterone replacement
Time frame: 24 months
Differences in non-targeted serum and skeletal muscle metabolomics in men
To compare differences in steroid metabolomics in men with prostate cancer pre- and post-androgen deprivation therapy (ADT)
Time frame: 24 months
Differences in steroid metabolomics in men with prostate cancer pre- and post-androgen deprivation therapy (ADT)
4 secondary outcomes
To compare differences in steroid metabolomics in men with hypogonadism compared to controls
Time frame: 24 months
To compare differences in steroid metabolomics in men with hypogonadism pre and post testosterone replacement
Time frame: 24 months
To compare differences in steroid metabolomics in men with prostate cancer pre- and post-androgen deprivation therapy
Time frame: 24 months
To compare differences in metabolic phenotype in (i) hypogonadal men compared to healthy men (ii) hypogonadal men pre and post testosterone replacement therapy (iii) men with prostate cancer post initiation of Androgen Deprivation Therapy
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
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 Hypogonadism, Male and Testosterone Deficiency, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael O' Reilly, FRCPI PhD (018093894, michaelworeilly@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare differences in non-targeted serum and skeletal muscle metabolomics in men with hypogonadism compared to controls (time frame: 24 months). The study lists 3 primary outcomes in all. 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 17 Mar 2023.