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CompletedNCT04326673SalTUpdated Jan 6, 2025

Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses

An observational study in Hypogonadism, Male, sponsored by The Royal Wolverhampton Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to male participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by The Royal Wolverhampton Hospitals NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
20 Years to 60 Years
Sex
Male
01

Study 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.

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.

02

Conditions studied

  • Hypogonadism, Male

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03

In context

Eunuchism

75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.

This study's enrollment of 40 is below the median of 100 across 17 observational studies indexed under Eunuchism.

Browse Eunuchism studies →

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust is the lead sponsor of 51 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers and patients attending hospital for their OGTT as part of their stnadard care.

Eligibility criteria

For 1st part of study -volunteers:

Inclusion Criteria:

  • Aged 20-60 years
  • Male

Exclusion Criteria:

  • 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.
  • 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 (BMI) of greater than 29.9 kg/m2As

    2nd part of study for glucose load - oral glucose tolerance test (OGTT):

Inclusion criteria:

  • Aged over 40-60 years.
  • Attending for routine 75 g OGTT

Exclusion criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • diurnal variation assessment

    Assessment of diurnal variation in salivary testosterone adjusted for prandial state

    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

    Other: Testosterone Measurements after glucose loading

Interventions

  • OtherTestosterone Measurements in healthy volunteers after fasting

    salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken

  • OtherTestosterone Measurements after glucose loading

    salivary tstosterone and blood testosterone measurements

06

What researchers measure

Primary outcomes

  1. Changes in salivary testosterone during the day independent of prandial state

    testosterone levels

    Time frame: 24 hours

  2. Changes in salivary testosterone following an oral glucose load

    testosterone levels

    Time frame: 2 hours

07

Study locations

1 site
  • The Royal Wolverhampton NHS Trust
    Wolverhampton, West Midlands WV10 0QP, United Kingdom
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04326673
Lead sponsor
The Royal Wolverhampton Hospitals NHS Trust
Responsible party
Sponsor
First posted
Mar 30, 2020
Start date
Oct 30, 2020
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023
Last update
Jan 6, 2025

Study contacts

R Gama
principal investigator · The Royal Wolverhampton NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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