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OpenTrials
Completed

NCT Number: NCT04326673

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.

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Key information

Age range

20 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone Measurements in healthy volunteers after fasting

Other

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

Testosterone Measurements after glucose loading

Other

salivary tstosterone and blood testosterone measurements

Primary outcomes

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

    Time frame: 24 hours

    testosterone levels

  2. Changes in salivary testosterone following an oral glucose load

    Time frame: 2 hours

    testosterone levels

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Registry information

Acronym: SalT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2020
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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