Value of 25 mcg Cortrosyn Stimulation Test - Full Text View

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: 1 ug ACTH stimulation test Procedure: 250 ug ACTH stimulation test Procedure: 25 ug Cortrosyn stimulation test Procedure: Insulin tolerance test


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: Every participant underwent the four interventional tests in random sequence Masking: No masking 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: 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:

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:

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)


Enrollment:	22
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: 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

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Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Investigators


Principal Investigator:	Seenia Peechakara, MD	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
Results First Received:	November 30, 2016
Last Updated:	April 9, 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

ClinicalTrials.gov processed this record on July 24, 2017

Value of 25 mcg Cortrosyn Stimulation Test (25CST)