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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-30

Study Completion Date

2023-10-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypogonadism, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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diurnal variation assessment

Assessment of diurnal variation in salivary testosterone adjusted for prandial state

Testosterone Measurements in healthy volunteers after fasting

Intervention Type OTHER

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

Testosterone Measurements after glucose loading

Intervention Type OTHER

salivary tstosterone and blood testosterone measurements

Interventions

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Testosterone Measurements in healthy volunteers after fasting

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

Intervention Type OTHER

Testosterone Measurements after glucose loading

salivary tstosterone and blood testosterone measurements

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 20-60 years
* Male

* Aged over 40-60 years.
* Attending for routine 75 g OGTT

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):

* 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes