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

Completed

• Conditions: Hypogonadism, Male
• Interventions: Other: Testosterone Measurements after glucose loading; Other: Testosterone Measurements in healthy volunteers after fasting

• Registration Number: NCT04326673
• Lead Sponsor: The Royal Wolverhampton Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Study Start: 2020-10-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glucose load measurements	Testosterone Measurements after glucose loading	Measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load
diurnal variation assessment	Testosterone Measurements in healthy volunteers after fasting	Assessment of diurnal variation in salivary testosterone adjusted for prandial state

Primary Outcome Measures

Name	Time	Method
Changes in salivary testosterone during the day independent of prandial state	24 hours	testosterone levels
Changes in salivary testosterone following an oral glucose load	2 hours	testosterone levels

Trial Locations

Locations (1)

The Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, West Midlands, United Kingdom