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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: June 22, 2017
Last verified: June 2017
  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: None (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:


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

  Show Detailed Description

  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: June 22, 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 August 22, 2017