Hypogonadism, Male
Conditions
Brief 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.
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.
Interventions
OTHERTestosterone Measurements in healthy volunteers after fasting
salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken
OTHERTestosterone Measurements after glucose loading
salivary tstosterone and blood testosterone measurements
Sponsors
The Royal Wolverhampton Hospitals NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in salivary testosterone during the day independent of prandial state | 24 hours | testosterone levels |
| Changes in salivary testosterone following an oral glucose load | 2 hours | testosterone levels |
Countries
United Kingdom
Outcome results
None listed