NCT04700020

An Assessment of the Occurrence of Hormone Deficiency in Patients With Empty Sella

(Partial) Empty Sella - Incidental Finding or the Cause of Hormonal Dysregulation?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this prospective study is to analyse the hormonal components in the blood of patients that were diagnosed with empty sella. Hereby we only take the hormones into consideration that are produced by the pituitary gland and/or are influenced by it due to positive/negative feedback. These are GH, ACTH, TSH, FSH, LH, PRL, oxytocine, ADH but also IGF-1, estradiol, testosteron, F4 and cortisol. The purpose is to see if abnormalities of the blook levels can be explained by the absence/shrinking of the pituitary gland. During this study, there will be a blood draw twice. The reason is to avoid wrong positive and negative results. Together with the second blood draw, there will be an insuline tolerance test in all patients. MRI will only be done if the last taken image is more than two years old or if the MRI was not taken with main focus on the pituitary gland.

Conditions

• Empty Sella

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ITT	In the context of this study, we will take two blood samples. In addition to the second blood sample, an insulin tolerance test (ITT) is also performed, even if the result of the blood values is normal. MRI will only be performed if the previous imaging was done more than two years ago or when the quality of the MRI was not good enough to measure the volume of the pituitary gland. This is needed for better analysis of the pituitary gland, as the pituitary volume could be important for the hormonal abnormalities.

Timeline

• Start date: 2019-10-14
• Primary completion: 2021-01-01
• Completion: 2021-05-01
• First posted: 2021-01-07
• Last updated: 2021-01-07

Locations

1 site across 1 country: Belgium