Value of 25 mcg Cortrosyn Stimulation Test (25CST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01428336
First received: September 1, 2011
Last updated: July 30, 2014
Last verified: July 2014
  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:


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 ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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
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

Contacts
Contact: Amir Hamrahian, MD 216-445-8538 hamraha@ccf.org
Contact: Seenia Peechakara, MD 216-445-5411 peechas@ccf.org

Locations
United States, Ohio
Cleveland Clinic Department of Endocrinology Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amir Hamrahian, MD    216-445-8538    hamraha@ccf.org   
Contact: Seenia Peechakara, MD    216-445-5411    peechas@ccf.org   
Principal Investigator: Amir Hamrahian, MD         
Sub-Investigator: Seenia Peechakara, MD         
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

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: July 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Cosyntropin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014