Age-related Differences in Response to Pituitary Stimulation Tests

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04572139
• Other study ID #: N-20200008
• Status: Recruiting
• Start date: September 23, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Aalborg University Hospital
• Contact: Johannes R Jensen, Bsc. med
• Phone: 97665185
• Email: johannes.j[@]rn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Pituitary
• Pituitary Diseases

Intervention

Diagnostic Test:
• Pituitary stimulation test
Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH

Locations

Country	Name	City	State
Denmark	Department of Geriatric Medicine, Aalborg University Hospital	Aalborg	Northen Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in peak values in TSH	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Other	Differences in peak values in Prolactin	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Other	Differences in peak values in LH	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Other	Differences in peak values in FSH	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Other	Differences in peak values in Cortisol	Both absolute peak values and peak values relative to basal level will be calculated.	Immediately after procedure.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.