Status:
COMPLETED
Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses
Lead Sponsor:
The Royal Wolverhampton Hospitals NHS Trust
Conditions:
Hypogonadism, Male
Eligibility:
MALE
20-60 years
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 ...
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...
Eligibility Criteria
Inclusion
- For 1st part of study -volunteers:
- Aged 20-60 years
- Male
Exclusion
- 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.
Key Trial Info
Start Date :
October 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04326673
Start Date
October 30 2020
End Date
October 30 2023
Last Update
January 6 2025
Active Locations (1)
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1
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP