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:
The Cleveland Clinic
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
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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
MedlinePlus related topics:
Diabetes Medicines
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 ]
| 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
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 Cosyntropin |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015