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

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

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 Overview

• Status: Unknown
• Conditions: Empty Sella
• Intervention / Treatment: Diagnostic test: ITT

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Jette
    • Brussels, Jette, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients above the age of 18 years; 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.

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.; Other Names: MRI; Blood Withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients that have hormone deficiency	The proportion of patients that have hormone deficiency when the condition "empty sella" is found on MRI or CT	Within two years after empty sella has been found on MRI or CT

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases; Empty Sella Syndrome
• Other Study ID Numbers: 2019/119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No