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

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.

Study Overview

• Status: Completed
• Conditions: Hypogonadism, Male
• Intervention / Treatment: Other: Testosterone Measurements in healthy volunteers after fasting; Other: Testosterone Measurements after glucose loading

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diurnal variation assessment; Assessment of diurnal variation in salivary testosterone adjusted for prandial state	Other: Testosterone Measurements in healthy volunteers after fasting; salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken
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; salivary tstosterone and blood testosterone measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in salivary testosterone during the day independent of prandial state	testosterone levels	24 hours
Changes in salivary testosterone following an oral glucose load	testosterone levels	2 hours

Collaborators and Investigators

• Sponsor: The Royal Wolverhampton Hospitals NHS Trust
• Investigators: Principal Investigator: R Gama, The Royal Wolverhampton NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Eunuchism; Antineoplastic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anabolic Agents; Androgens; Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
• Other Study ID Numbers: 2020LAB110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No