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Value of 25 mcg Cortrosyn Stimulation Test

NCT01428336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-07-25

Study results available
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Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Seenia Peechakara, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428336 on ClinicalTrials.gov