Value of 25 mcg Cortrosyn Stimulation Test (25CST)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT01428336

First received: September 1, 2011

Last updated: November 4, 2015

Last verified: November 2015

History of Changes

Purpose

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	Intervention
Adrenal Insufficiency	Procedure: ACTH stimulation test Procedure: 250 ug ACTH stimulation test Procedure: 25 ug Cortrosyn stimulation test Procedure: Insulin tolerance test Procedure: 1 ug cortrosyn test


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	The Value of 25 mcg Cortrosyn Stimulation Test to Assess Adult HPA Axis

Resource links provided by NLM:

Genetics Home Reference related topics: familial glucocorticoid deficiency

Drug Information available for: Insulin Insulin human Cosyntropin

Genetic and Rare Diseases Information Center resources: Hypoadrenalism

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Peak cortisol values [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACTH level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]


Enrollment:	23
Study Start Date:	September 2011
Study Completion Date:	January 2015
Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1ug cortrosyn dose stimulation test Subjects will undergo an ACTH stimulation test using a dose of 1 ug cotrosyn	Procedure: ACTH stimulation test 1 ug cortrosyn dose Procedure: 1 ug cortrosyn test Subjects will undergo an ACTH test using a 1 ug dose cortrosyn
Active Comparator: 250 ug cortrosyn dose stimulation test Subjects will undergo an ACTH stimulation test using 250 ug cortrosyn dose	Procedure: 250 ug ACTH stimulation test ACTH stimulation test will be done using 250 ug cortrosyn dose
Experimental: 25 ug cortrosyn stimulation test Subjects will undergo an ACTH stimulation test using a 25 ug cortosyn dose	Procedure: 25 ug Cortrosyn stimulation test ACTH stimulation test using a 25 ug cortrosyn dose
Active Comparator: Insulin tolerance test Subjects will undergo an Insulin Tolerance Test	Procedure: Insulin tolerance test subjects will undergo an insulin tolerance test

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01428336

Locations


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

Sponsors and Collaborators

The Cleveland Clinic

More Information


Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01428336 History of Changes
Other Study ID Numbers:	1945
Study First Received:	September 1, 2011
Last Updated:	November 4, 2015
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Insulin, Globin Zinc Insulin Adrenocorticotropic Hormone	Cosyntropin Hypoglycemic Agents Physiological Effects of Drugs Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016

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