Central Hypothyroidism, a Novel Laboratory Measurement

Central Hypothyroidism,a New Laboratory Approach for Hormone Measurement

Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.

Study Overview

• Status: Unknown
• Conditions: Central Hypothyroidism
• Intervention / Treatment: Drug: Eltroxin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH

Exclusion Criteria:

• Primary hypothyroidism

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
free T4 levels	a year

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptoms of hypothyroidism	a year

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Ruth Percik, M.D., Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 20, 2011

Study Record Updates

• Last Update Posted (Estimate): February 3, 2011
• Last Update Submitted That Met QC Criteria: February 2, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: central hypothyroidism, hypopituitarism, eltroxin
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: SHEBA-10-8213-RP-CTIL