Adrenal Insufficiency Clinical Trial
— 25CSTOfficial title:
The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Department of Endocrinology | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak cortisol values | 4 hours | No | |
Secondary | ACTH level | 6 hours | No |
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