N/A N=22 Randomized Diagnostic

Value of 25 mcg Cortrosyn Stimulation Test

Adrenal Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01428336 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs — 0.8; 0.86; 0.93; 0.92 correlation coefficient

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 1 ug ACTH stimulation test (Procedure); 250 ug ACTH stimulation test (Procedure); 25 ug Cortrosyn stimulation test (Procedure); Insulin tolerance test (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs	0.8; 0.86; 0.93; 0.92	—
SECONDARY Pearson Correlation of Free Cortisol Values During CSTs With ITT	0.58; 0.70; 0.88; 0.89	—
SECONDARY Peak Total Cortisol Values	23.3; 16.6; 23.4; 14.5; 22.0; 17.4	—

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.

Eligibility Criteria

Inclusion Criteria

hypothalamic-pituitary-adrenal disorders

Exclusion Criteria

under 18 or older than 65 years of age

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Data sourced from ClinicalTrials.gov (NCT01428336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.