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

NCT ID: NCT04700020

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2021-05-31

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.

Conditions

Empty Sella

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

ITT

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

MRI; Blood Withdrawal

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Brussels, Jette, Belgium

Countries

Belgium

Other Identifiers

2019/119

Identifier Type: -

Identifier Source: org_study_id