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

The Royal Wolverhampton Hospitals NHS Trust

Status

Completed

Conditions

Hypogonadism, Male

Treatments

Other: Testosterone Measurements after glucose loading

Other: Testosterone Measurements in healthy volunteers after fasting

Study type

Observational

Funder types

Other

Identifiers

NCT04326673

2020LAB110

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Male

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.