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

NCT04326673 | Completed

• 1 other identifier: 2020LAB110
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism, Male

Outcome Measures

Primary Outcomes (2)

• Changes in salivary testosterone during the day independent of prandial state

  testosterone levels

  24 hours

• Changes in salivary testosterone following an oral glucose load

  testosterone levels

  2 hours

Study Arms (2)

diurnal variation assessment

Assessment of diurnal variation in salivary testosterone adjusted for prandial state

Other: Testosterone Measurements in healthy volunteers after fasting

Glucose load measurements

Measurement of salivary and serum testosterone and related biomarkers before and after a standard 75g oral glucose load

Other: Testosterone Measurements after glucose loading

Interventions

Testosterone Measurements in healthy volunteers after fasting OTHER

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

diurnal variation assessment

Testosterone Measurements after glucose loading OTHER

salivary tstosterone and blood testosterone measurements

Glucose load measurements

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients attending hospital for their OGTT as part of their stnadard care.

You may qualify if:

• Aged 20-60 years
• Male

You may not qualify if:

• 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
• nd part of study for glucose load - oral glucose tolerance test (OGTT):
• Aged over 40-60 years.
• Attending for routine 75 g 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.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Related Publications (1)

• Fenn J, Gill H, Starbrook L, Ford L, Sharrod-Cole H, Kalaria T, Ford C, Gama R. Salivary testosterone changes during oral glucose tolerance tests in overweight and obese men - Postprandial or circadian variation? Ann Clin Biochem. 2024 Sep;61(5):391-398. doi: 10.1177/00045632241249087. Epub 2024 May 9.

  PMID: 38591370 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and saliva samples

MeSH Terms

Conditions

Eunuchism

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Study Officials

• R Gama

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: October 30, 2020
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)