Salivary Testosterone in Men: Diurnal Variation and Post-... | NCT04326673

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

NCT04326673

Sponsor

The Royal Wolverhampton Hospitals NHS Trust

Status

Completed

Last Update Posted

Jan 6, 2025Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Hypogonadism, Male

Interventions

Testosterone Measurements in healthy volunteers after fasting
Testosterone Measurements after glucose loading

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2020Actual

Primary Completion Date

Oct 30, 2023Actual

Completion Date

Oct 30, 2023Actual

First Submitted Date

Mar 26, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2025

Last Update Posted Date

Jan 6, 2025Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Testosterone Measurements in healthy volunteers after fasting	Other	salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken

Measure	Description	Time Frame
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

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D007006	Hypogonadism
D006058	Gonadal Disorders
D004700	Endocrine System Diseases