Age-related Differences in Response to Pituitary Stimulation Tests

Age-related Differences in the Response to a Combined Pituitary Stimulation Test With TRH, LHRH and ACTH

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

Study Overview

• Status: Completed
• Conditions: Aging; Pituitary
• Intervention / Treatment: Diagnostic test: Pituitary stimulation test

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Denmark
  • Northen Jutland
    • Aalborg, Northen Jutland, Denmark, 9000
      • Department of Geriatric Medicine, Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young participants; 18-45 years old	Diagnostic test: Pituitary stimulation test; Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH
Old participants; 55-80 years old	Diagnostic test: Pituitary stimulation test; Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH
Oldest old participants; over 80 years old	Diagnostic test: Pituitary stimulation test; Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in peak values in TSH	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Differences in peak values in Prolactin	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Differences in peak values in LH	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Differences in peak values in FSH	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Differences in peak values in Cortisol	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Differences in time to peak for TSH.	Delayed responses will be examined by inspecting curves and by comparing area under the curve at the different blood sampling time points during the test.	Immediately after procedure.
Differences in time to peak for Prolactin.	Delayed responses will be examined by inspecting curves and by comparing area under the curve at the different blood sampling time points during the test.	Immediately after procedure.
Differences in time to peak for LH.	Delayed responses will be examined by inspecting curves and by comparing area under the curve at the different blood sampling time points during the test.	Immediately after procedure.
Differences in time to peak for FSH.	Delayed responses will be examined by inspecting curves and by comparing area under the curve at the different blood sampling time points during the test.	Immediately after procedure.
Differences in time to peak for Cortisol.	Delayed responses will be examined by inspecting curves and by comparing area under the curve at the different blood sampling time points during the test.	Immediately after procedure.

Collaborators and Investigators

• Sponsor: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 26, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases
• Other Study ID Numbers: N-20200008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No