Value of 25 mcg Cortrosyn Stimulation Test (25CST)

Study Description

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Brief 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.

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

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	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
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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• hypothalamic-pituitary-adrenal disorders

Exclusion Criteria:

• under 18 or older than 65 years of age

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
Cleveland Clinic Department of Endocrinology
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator:	Seenia Peechakara, MD	The Cleveland Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01428336 History of Changes
Other Study ID Numbers:	1945
First Posted:	September 2, 2011
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