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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01428336
Other study ID # 1945
Secondary ID
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


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
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