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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Value of 25 mcg Cortrosyn Stimulation Test

Short name 25CST

NCTNCT01428336 (opens ClinicalTrials.gov in a new tab)Other id1945
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
22 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2011
Primary completion
Jan 2015
Completion
Jan 2015
First posted
2 Sept 2011 (estimated)
Last update posted
25 Jul 2017
Conditions
Adrenal Insufficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. N/A

    25CST

    NCT01428336

    Sept 2011 to Jan 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 1 ug ACTH stimulation testProcedure
  • 250 ug ACTH stimulation testProcedure
  • 25 ug Cortrosyn stimulation testProcedure
  • Insulin tolerance testProcedure

Arms2

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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 outcomes(2)

  1. 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

    Registry description

    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

  2. Peak Total Cortisol Values

    Time frame · 1 hour for the CST interventions and 2 hour for the ITT interventions

    Registry description

    Peak total cortisol values during cortrosyn stimulation tests(CST)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 1 hour for the CST interventions and 2 hour for the ITT interventions

Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs

GroupValue (correlation coefficient)
Patients + Volunteers0.8
Secondary and other outcome results(2)
Secondary outcomeNumber· 1 hour for the CST interventions and 2 hour for the ITT interventions

Pearson Correlation of Free Cortisol Values During CSTs With ITT

GroupValue (correlation coefficient)
Patients + Volunteers0.58
Secondary outcomeMedian· 1 hour for the CST interventions and 2 hour for the ITT interventions

Peak Total Cortisol Values

GroupValue (ug/dl)
Patients23.3
Volunteers16.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1ug Cortrosyn Dose Stimulation TestSubjects will undergo an ACTH stimulation test using a dose of 1 ug cotrosyn ACTH stimulation test: 1 ug cortrosyn dose 1 ug cortrosyn test: Subjects will undergo an ACTH test using a 1 ug dose cortrosyn–0 / 220 / 22
250 ug Cortrosyn Dose Stimulation TestSubjects will undergo an ACTH stimulation test using 250 ug cortrosyn dose 250 ug ACTH stimulation test: ACTH stimulation test will be done using 250 ug cortrosyn dose–0 / 220 / 22
25 ug Cortrosyn Stimulation TestSubjects will undergo an ACTH stimulation test using a 25 ug cortosyn dose 25 ug Cortrosyn stimulation test: ACTH stimulation test using a 25 ug cortrosyn dose–0 / 220 / 22
Insulin Tolerance TestSubjects will undergo an Insulin Tolerance Test Insulin tolerance test: subjects will undergo an insulin tolerance test–0 / 220 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * hypothalamic-pituitary-adrenal disorders Exclusion Criteria: * under 18 or older than 65 years of age

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