Clinical trial NCT04326673: Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses
Official title: Salivary Testosterone in Men: Diurnal Variation and Post-prandial Responses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism, Male
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2020-03-30
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and patients attending hospital for their OGTT as part of their stnadard care.

Brief 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.

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.

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 body mass index (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.

Primary outcomes:
measure: Changes in salivary testosterone during the day independent of prandial state
timeFrame: 24 hours
measure: Changes in salivary testosterone following an oral glucose load
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: R Gama
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.