Age-related Differences in Response to Pituitary Stimulation Tests

Recruiting

• Conditions: Pituitary; Aging
• Interventions: Diagnostic Test: Pituitary stimulation test

• Registration Number: NCT04572139
• Lead Sponsor: Aalborg University Hospital

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.

Study Timeline

• Study Start: 2020-09-23
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-10-01
• Primary Completion: 2022-12-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young participants	Pituitary stimulation test	18-45 years old
Old participants	Pituitary stimulation test	55-80 years old
Oldest old participants	Pituitary stimulation test	over 80 years old

Primary Outcome Measures

Name	Time	Method
Differences in area under the curve in TSH.	Immediately after procedure.	Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in LH.	Immediately after procedure.	Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in Cortisol.	Immediately after procedure.	Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in Prolactin.	Immediately after procedure.	Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in FSH.	Immediately after procedure.	Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.

Trial Locations

Locations (1)

Department of Geriatric Medicine, Aalborg University Hospital; 🇩🇰 Aalborg, Northen Jutland, Denmark