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Value of 25 mcg Cortrosyn Stimulation Test (25CST)

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ClinicalTrials.gov Identifier: NCT01428336
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : June 23, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Adrenal Insufficiency
Interventions Procedure: 1 ug ACTH stimulation test
Procedure: 250 ug ACTH stimulation test
Procedure: 25 ug Cortrosyn stimulation test
Procedure: Insulin tolerance test
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Volunteers
Hide Arm/Group Description Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
Period Title: Overall Study
Started 10 12
Completed 10 12
Not Completed 0 0
Arm/Group Title Patients Volunteers Total
Hide Arm/Group Description Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test Total of all reporting groups
Overall Number of Baseline Participants 10 12 22
Hide Baseline Analysis Population Description
Every participant underwent three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
12
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 22 participants
Female
2
  20.0%
6
  50.0%
8
  36.4%
Male
8
  80.0%
6
  50.0%
14
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 22 participants
10 12 22
1.Primary Outcome
Title Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs
Hide 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
Time Frame 1 hour for the CST interventions and 2 hour for the ITT interventions
Hide Outcome Measure Data
Hide Analysis Population Description
Correlation of total cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.
Arm/Group Title Patients + Volunteers
Hide Arm/Group Description:
Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
Peak 1 ug ACTH stimulation test
0.8
(0.57 to 0.91)
Peak 25 ug ACTH stimultion test
0.86
(0.69 to 0.94)
60-minute 250ug ACTH stimulation test
0.93
(0.83 to 0.97)
30-minute 250ug ACTH stimulation test
0.92
(0.82 to 0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients + Volunteers
Comments Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT
Type of Statistical Test Non-Inferiority
Comments A non-inferiority region of 0.15 for the difference in correlations is expected.
Method of Estimation Estimation Parameter Difference in correlation
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.20 to 0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients + Volunteers
Comments Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT
Type of Statistical Test Non-Inferiority
Comments A non-inferiority region of 0.15 for the difference in correlations is expected.
Method of Estimation Estimation Parameter Difference in correlation
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.69 to -0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients + Volunteers
Comments Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT
Type of Statistical Test Non-Inferiority
Comments A non-inferiority region of 0.15 for the difference in correlations is expected.
Method of Estimation Estimation Parameter Difference in correlation
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.65 to 0.04
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pearson Correlation of Free Cortisol Values During CSTs With ITT
Hide 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
Time Frame 1 hour for the CST interventions and 2 hour for the ITT interventions
Hide Outcome Measure Data
Hide Analysis Population Description
Correlation of free cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.
Arm/Group Title Patients + Volunteers
Hide Arm/Group Description:
Every participant underwent three ACTH stimulation test and one Insulin tolerance test.
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: correlation coefficient
Peak 1ug ACTH stimulation test
0.58
(0.20 to 0.80)
Peak 25ug ACTH stimulation test
0.70
(0.39 to 0.87)
60- minute 250ug ACTH stimulation test
0.88
(0.74 to 0.95)
30-minute 250ug ACTH stimulation test
0.89
(0.74 to 0.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients + Volunteers
Comments Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol
Type of Statistical Test Non-Inferiority
Comments A non-inferiority region of 0.15 for the difference in correlations is expected.
Method of Estimation Estimation Parameter Difference in correlation
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.24 to 0.65
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients + Volunteers
Comments Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol
Type of Statistical Test Non-Inferiority
Comments A non-inferiority region of 0.15 for the difference in correlations is expected.
Method of Estimation Estimation Parameter Difference in correlation
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.91 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients + Volunteers
Comments Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol
Type of Statistical Test Non-Inferiority
Comments A non-inferiority region of 0.15 for the difference in correlations is expected.
Method of Estimation Estimation Parameter Difference in correlation
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.94 to -0.14
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Peak Total Cortisol Values
Hide Description Peak total cortisol values during cortrosyn stimulation tests(CST)
Time Frame 1 hour for the CST interventions and 2 hour for the ITT interventions
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Volunteers
Hide Arm/Group Description:
Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
Overall Number of Participants Analyzed 10 12
Median (Full Range)
Unit of Measure: ug/dl
Insulin Tolerance Test
23.3
(20.2 to 25.9)
16.6
(1.1 to 26.1)
1 ug ACTH stimulation test
23.4
(16.7 to 31.9)
14.5
(2.2 to 28.4)
25 ug ACTH stimulation test
22.0
(16.4 to 28.6)
17.4
(2.0 to 24.9)
30 min 250 ug ACTH stimulation test
22.3
(18.8 to 27.8)
16.1
(1.8 to 25.8)
60 min 250 ug ACTH simulation test
25.0
(21.9 to 31.5)
19.1
(2.4 to 29.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1ug Cortrosyn Dose Stimulation Test 250 ug Cortrosyn Dose Stimulation Test 25 ug Cortrosyn Stimulation Test Insulin Tolerance Test
Hide Arm/Group Description

Subjects 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

Subjects 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

Subjects 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

Subjects will undergo an Insulin Tolerance Test

Insulin tolerance test: subjects will undergo an insulin tolerance test

All-Cause Mortality
1ug Cortrosyn Dose Stimulation Test 250 ug Cortrosyn Dose Stimulation Test 25 ug Cortrosyn Stimulation Test Insulin Tolerance Test
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1ug Cortrosyn Dose Stimulation Test 250 ug Cortrosyn Dose Stimulation Test 25 ug Cortrosyn Stimulation Test Insulin Tolerance Test
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1ug Cortrosyn Dose Stimulation Test 250 ug Cortrosyn Dose Stimulation Test 25 ug Cortrosyn Stimulation Test Insulin Tolerance Test
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Small number of participants Cortisol Binding globulin was not measured
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Seenia Peechakara
Organization: Cleveland Clinic Foundation
Phone: 216 4105901
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01428336     History of Changes
Other Study ID Numbers: 1945
First Submitted: September 1, 2011
First Posted: September 2, 2011
Results First Submitted: November 30, 2016
Results First Posted: June 23, 2017
Last Update Posted: July 25, 2017