CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
1 ug ACTH stimulation test +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01428336
NCT01428336N/ACompleted
CompareCT.gov

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

The Cleveland Clinic·interventional·Posted Sep 2, 2011·Updated Jul 25, 2017

In Brief

A clinical study evaluating 1 ug ACTH stimulation test, 250 ug ACTH stimulation test, and 2 other interventions for Adrenal Insufficiency. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdrenal Insufficiency
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2011
Enrollment StartSep 1, 2011
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.8 years ago

Interventions

1 ug ACTH stimulation testprocedure

1 ug cortrosyn dose

250 ug ACTH stimulation testprocedure

ACTH stimulation test will be done using 250 ug cortrosyn dose

25 ug Cortrosyn stimulation testprocedure

ACTH stimulation test using a 25 ug cortrosyn dose

Insulin tolerance testprocedure

subjects will undergo an insulin tolerance test