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

Hypogonadism, Male Clinical Trial

— Sal T  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326673
• Other study ID #: 2020LAB110
• Status: Completed
• Start date: October 30, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: May 2024
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The ultimate aim is to add Sal-T into the Trust's repertoire of tests in investigating suspected hypogonadism in men.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male

Intervention

Other:
• Testosterone Measurements in healthy volunteers after fasting
salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken
• Testosterone Measurements after glucose loading
salivary tstosterone and blood testosterone measurements

Locations

Country	Name	City	State
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Wolverhampton Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Fenn J, Gill H, Starbrook L, Ford LT, 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 Apr 9:456322412490 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in salivary testosterone during the day independent of prandial state	testosterone levels	24 hours
Primary	Changes in salivary testosterone following an oral glucose load	testosterone levels	2 hours