Hypogonadism, MaleSalTNCT04326673
Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses
An observational study of Hypogonadism, Male, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose is to evaluate Sal-T against standard biomarkers of male gonadal status based on serum T, calculated free T and BAT. The optimal salivary sampling in terms of fasting and time of day will also be defined. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- Testosterone Measurements in healthy volunteers after fasting and Testosterone Measurements after glucose loading
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2020to 30 Oct 2023
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers and patients attending hospital for their OGTT as part of their stnadard care.
Who may be able to join
- Aged 20-60 years
- Male
- Aged over 40-60 years.
- Attending for routine 75 g OGTT
Who cannot join
- Subjects with learning disability or those lacking mental capacity to give consent.
- On (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism.
- Known hypogonadism.
- Conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction.
- Any co-morbidity.
- Periodontal disease.
Show all 20Show fewer
- Dental work 48 hours prior to the test.
- Exercise on the day, prior to and during sampling periods.
- Brushed teeth within 1hr prior to sample collection.
- Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2As
- 2nd part of study for glucose load - oral glucose tolerance test (OGTT):
- Subjects with learning disability or lacking mental capacity to give consent.
- On (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism.
- Known hypogonadism.
- Conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction.
- Subjects with difficult venous access.
- Periodontal disease.
- Dental work 48 hours prior to the test.
- Brushed teeth within 1hour prior to sample collection.
- Exercise on day prior to and during the OGTT.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
About this study
Official title: Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses
The purpose is to evaluate Sal-T against standard biomarkers of male gonadal status based on serum T, calculated free T and BAT. The optimal salivary sampling in terms of fasting and time of day will also be defined.
The ultimate aim is to add Sal-T into the Trust's repertoire of tests in investigating suspected hypogonadism in men.
Read the detailed description
To investigate whether salivary (free) testosterone is subject to similar prandial variations reported for serum total testosterone.
Study 1:
Assessment of diurnal variation in salivary testosterone adjusted for prandial state in 20 healthy men.
Study 2:
Measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load in 40 men.
- Conditions
- Hypogonadism, Male
- Being tested
- Testosterone Measurements in healthy volunteers after fasting, Testosterone Measurements after glucose loading
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Measurements in healthy volunteers after fastingOther
salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken
Testosterone Measurements after glucose loadingOther
salivary tstosterone and blood testosterone measurements
| Study group | Role | What they receive |
|---|---|---|
| diurnal variation assessment | Assessment of diurnal variation in salivary testosterone adjusted for prandial state Receives: Other: Testosterone Measurements in healthy volunteers after fasting | |
| Glucose load measurements | Measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load Receives: Other: Testosterone Measurements after glucose loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in salivary testosterone during the day independent of prandial state
testosterone levels
Measured: 24 hours
Changes in salivary testosterone following an oral glucose load
testosterone levels
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start30 Oct 2020
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- R Gama, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326673
- Sponsor's protocol ID
- 2020LAB110
- Acronym
- SalT
- Status last verified
- Jan 2025
- First submitted
- 26 Mar 2020
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fenn J, Gill H, Starbrook L, Ford L, Sharrod-Cole H, Kalaria T, Ford C, Gama R. Salivary testosterone changes during oral glucose tolerance tests in overweight and obese men - Postprandial or circadian variation? Ann Clin Biochem. 2024 Sep;61(5):391-398. doi: 10.1177/00045632241249087. Epub 2024 May 9.
PubMed 38591370
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses
- ClinicalTrials.gov ID
- NCT04326673
- Acronym / sponsor ID
- SalT / 2020LAB110
- Conditions
- Hypogonadism, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 30 Mar 2020 (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.
The purpose is to evaluate Sal-T against standard biomarkers of male gonadal status based on serum T, calculated free T and BAT. The optimal salivary sampling in terms of fasting and time of day will also be defined.
The ultimate aim is to add Sal-T into the Trust's repertoire of tests in investigating suspected hypogonadism in men.
Detailed description
To investigate whether salivary (free) testosterone is subject to similar prandial variations reported for serum total testosterone.
Study 1:
Assessment of diurnal variation in salivary testosterone adjusted for prandial state in 20 healthy men.
Study 2:
Measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load in 40 men.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diurnal variation assessment | – | Other: Testosterone Measurements in healthy volunteers after fastingAssessment of diurnal variation in salivary testosterone adjusted for prandial state |
| Glucose load measurements | – | Other: Testosterone Measurements after glucose loadingMeasurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers and patients attending hospital for their OGTT as part of their stnadard care.
Key inclusion criteria (4 listed)
- Aged 20-60 years
- Male
- Aged over 40-60 years.
- Attending for routine 75 g OGTT
Key exclusion criteria (20 listed)
- Subjects with learning disability or those lacking mental capacity to give consent.
- On (prescribed and over-the-counter) medication and herbal remedies known to affect androgen metabolism.
- Known hypogonadism.
- Conditions known to affect androgen metabolism, including chronic inflammatory diseases, chronic liver disease, chronic kidney disease and thyroid dysfunction.
- Any co-morbidity.
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 |
|---|---|---|
| Testosterone Measurements in healthy volunteers after fastingsalivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken | Other | diurnal variation assessment |
| Testosterone Measurements after glucose loadingsalivary tstosterone and blood testosterone measurements | Other | Glucose load measurements |
Primary outcome
Changes in salivary testosterone during the day independent of prandial state
Time frame: 24 hours
testosterone levels
Changes in salivary testosterone following an oral glucose load
Time frame: 2 hours
testosterone levels
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 6 Jan 2025.
- Results publication: PubMed 38591370Fenn J, Gill H, Starbrook L, Ford L, Sharrod-Cole H, Kalaria T, Ford C, Gama R. Salivary testosterone changes during oral glucose tolerance tests in overweight and obese men - Postprandial or circadian variation? Ann Clin Biochem. 2024 Sep;61(5):391-398. doi: 10.1177/00045632241249087. Epub 2024 May 9.
- 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.
R Gama principal investigator
The Royal Wolverhampton NHS Trust
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, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 20 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 6 Jan 2025. 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 United Kingdom. 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?
Changes in salivary testosterone during the day independent of prandial state (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT04326673, which also lists 1 linked publication.
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 6 Jan 2025.