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

Brief Title

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

Official Title

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

Brief 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.
    



Study Type

Interventional


Primary Outcome

The proportion of patients that have hormone deficiency


Condition

Empty Sella

Intervention

ITT

Study Arms / Comparison Groups

 Patients above the age of 18 years
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

60

Start Date

October 14, 2019

Completion Date

May 2021

Primary Completion Date

January 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients that were diagnosed with an (partial) empty sella detected by MRI or CT of
             the brain have been included in this study. Whenever the MRI or CT scan was performed
             more than two years ago, a new MRI scan was required.

        Exclusion Criteria:

          -  Children (patients less than 18 years) and patients with earlier diagnosed carcinomas
             of the brain as well as patients with secondary empty sella (antecedents of radiation,
             pharmacological treatment of pituitary adenomas, traumatic head injury and surgery of
             the pituitary gland as well as the central nervous system) were not included.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04700020

Organization ID

2019/119


Responsible Party

Sponsor

Study Sponsor

Universitair Ziekenhuis Brussel


Study Sponsor

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Verification Date

December 2020