Value of 25 mcg Cortrosyn Stimulation Test

Adrenal Insufficiency Clinical Trial

— 25CST  

Official title:

The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428336
• Other study ID #: 1945
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: November 4, 2015
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The diagnosis of secondary AI is vital to prevent catastrophic events in patients. An optimal test should have a very low margin of error with high sensitivity and specificity, be easy and safe to administer, and have distinct cut off values. Both 1 ug and 250 ug doses have their limitations. Based on our experience over the past six years, we hypothesize that 25 ug ACTH stimulation test may eliminate some of the shortcomings of the LDST (1 ug) and SDST (250 ug). This is supported by our preliminary data and the study by Oelkers et al, which looked at ACTH levels following various doses of cortrosyn injections.

Therefore we propose a head to head comparison of 25 ug, 250 ug and 1 ug dose using ITT as gold standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• hypothalamic-pituitary-adrenal disorders

Exclusion Criteria:

• under 18 or older than 65 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Insufficiency

Intervention

Procedure:
• ACTH stimulation test
1 ug cortrosyn dose
• 250 ug ACTH stimulation test
ACTH stimulation test will be done using 250 ug cortrosyn dose
• 25 ug Cortrosyn stimulation test
ACTH stimulation test using a 25 ug cortrosyn dose
• Insulin tolerance test
subjects will undergo an insulin tolerance test
• 1 ug cortrosyn test
Subjects will undergo an ACTH test using a 1 ug dose cortrosyn

Locations

Country	Name	City	State
United States	Cleveland Clinic Department of Endocrinology	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak cortisol values		4 hours	No
Secondary	ACTH level		6 hours	No