Clinical trial NCT04572139: Age-related Differences in Response to Pituitary Stimulation Tests
Official title: Age-related Differences in the Response to a Combined Pituitary Stimulation Test With TRH, LHRH and ACTH
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pituitary
Aging
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults across different age groups without conditions affecting pituitary function. Minimum sample size has been determined by power calculation to be 15 participants. The study aims to include up 24 particpants to increase power in the primary analysis.

Brief summary: The purpose of this study to age-related differences to the response of a combined pituitary stimulation test with TRH, LHRH and ACTH.

Detailed description: Participants will be recruited in three different age intervals: 18-45 years, 55-80 years and 80+ years. These participants will all undergo the same stimulation test with 0.1 mg LHRH, 0.2 mg TRH, and 0.25 mg ACTH (Synachten). The tests will be perfomed at the same time of day for all particpants (between 08:15 and 08:45) and participants will be fasting for the test. Blood samples will be taken just before and at 10, 20, 30, 45, 60, 90 and 120 minutes following the stimulation test. Serum from blood samples will be stored at -20 degrees until analysis.

Eligibility criteria: Inclusion Criteria:

* Ages between 18-45 or above 55.
* Healthy Volunteers

Exclusion Criteria:

* Medication or conditions affecting pituitary response (such as hormonal birth control, steriod use, thyroid disorders)
* Pregnancy or birth within the last year
* inability to give informed consent

Primary outcomes:
measure: Differences in area under the curve in TSH.
timeFrame: Immediately after procedure.
measure: Differences in area under the curve in Prolactin.
timeFrame: Immediately after procedure.
measure: Differences in area under the curve in LH.
timeFrame: Immediately after procedure.
measure: Differences in area under the curve in FSH.
timeFrame: Immediately after procedure.
measure: Differences in area under the curve in Cortisol.
timeFrame: Immediately after procedure.
Secondary outcomes:
Other outcomes:
measure: Differences in peak values in TSH
timeFrame: Immediately after procedure.
measure: Differences in peak values in Prolactin
timeFrame: Immediately after procedure.
measure: Differences in peak values in LH
timeFrame: Immediately after procedure.
measure: Differences in peak values in FSH
timeFrame: Immediately after procedure.
measure: Differences in peak values in Cortisol
timeFrame: Immediately after procedure.
measure: Differences in time to peak for TSH.
timeFrame: Immediately after procedure.
measure: Differences in time to peak for Prolactin.
timeFrame: Immediately after procedure.
measure: Differences in time to peak for LH.
timeFrame: Immediately after procedure.
measure: Differences in time to peak for FSH.
timeFrame: Immediately after procedure.
measure: Differences in time to peak for Cortisol.
timeFrame: Immediately after procedure.
Locations:
city: Aalborg
country: Denmark
facility: Department of Geriatric Medicine, Aalborg University Hospital
state: Northen Jutland
Study officials:
References: