Value of 25 mcg Cortrosyn Stimulation Test (25CST)
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ClinicalTrials.gov Identifier: NCT01428336 |
Recruitment Status
:
Completed
First Posted
: September 2, 2011
Results First Posted
: June 23, 2017
Last Update Posted
: July 25, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adrenal Insufficiency | Procedure: 1 ug ACTH stimulation test Procedure: 250 ug ACTH stimulation test Procedure: 25 ug Cortrosyn stimulation test Procedure: Insulin tolerance test | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Every participant underwent the four interventional tests in random sequence |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Patients
Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
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Procedure: 1 ug ACTH stimulation test
1 ug cortrosyn dose
Procedure: 250 ug ACTH stimulation test
ACTH stimulation test will be done using 250 ug cortrosyn dose
Procedure: 25 ug Cortrosyn stimulation test
ACTH stimulation test using a 25 ug cortrosyn dose
Procedure: Insulin tolerance test
subjects will undergo an insulin tolerance test
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Active Comparator: Volunteers
Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
|
Procedure: 1 ug ACTH stimulation test
1 ug cortrosyn dose
Procedure: 250 ug ACTH stimulation test
ACTH stimulation test will be done using 250 ug cortrosyn dose
Procedure: 25 ug Cortrosyn stimulation test
ACTH stimulation test using a 25 ug cortrosyn dose
Procedure: Insulin tolerance test
subjects will undergo an insulin tolerance test
|
- Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs [ Time Frame: 1 hour for the CST interventions and 2 hour for the ITT interventions ]Correlation of total cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table
- Pearson Correlation of Free Cortisol Values During CSTs With ITT [ Time Frame: 1 hour for the CST interventions and 2 hour for the ITT interventions ]Correlation of free cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table
- Peak Total Cortisol Values [ Time Frame: 1 hour for the CST interventions and 2 hour for the ITT interventions ]Peak total cortisol values during cortrosyn stimulation tests(CST)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- hypothalamic-pituitary-adrenal disorders
Exclusion Criteria:
- under 18 or older than 65 years of age

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428336
United States, Ohio | |
Cleveland Clinic Department of Endocrinology | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Seenia Peechakara, MD | The Cleveland Clinic |
Responsible Party: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT01428336 History of Changes |
Other Study ID Numbers: |
1945 |
First Posted: | September 2, 2011 Key Record Dates |
Results First Posted: | June 23, 2017 |
Last Update Posted: | July 25, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Additional relevant MeSH terms:
Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Insulin, Globin Zinc Insulin Adrenocorticotropic Hormone Melanocyte-Stimulating Hormones Cosyntropin |
beta-Endorphin Hypoglycemic Agents Physiological Effects of Drugs Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |