Trial Outcomes & Findings for Value of 25 mcg Cortrosyn Stimulation Test (NCT NCT01428336)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

1 hour for the CST interventions and 2 hour for the ITT interventions

Results posted on

2017-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	10	12
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Value of 25 mcg Cortrosyn Stimulation Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=10 Participants Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test	Volunteers n=12 Participants 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 n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions

Population: 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.

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

Outcome measures

Outcome measures
Measure	Patients + Volunteers n=22 Participants Every participant underwent three ACTH stimulation test and one Insulin tolerance test.	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
Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs Peak 1 ug ACTH stimulation test	0.8 correlation coefficient Interval 0.57 to 0.91	—
Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs Peak 25 ug ACTH stimultion test	0.86 correlation coefficient Interval 0.69 to 0.94	—
Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs 60-minute 250ug ACTH stimulation test	0.93 correlation coefficient Interval 0.83 to 0.97	—
Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs 30-minute 250ug ACTH stimulation test	0.92 correlation coefficient Interval 0.82 to 0.97	—

SECONDARY outcome

Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions

Population: 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.

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

Outcome measures

Outcome measures
Measure	Patients + Volunteers n=22 Participants Every participant underwent three ACTH stimulation test and one Insulin tolerance test.	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
Pearson Correlation of Free Cortisol Values During CSTs With ITT Peak 1ug ACTH stimulation test	0.58 correlation coefficient Interval 0.2 to 0.8	—
Pearson Correlation of Free Cortisol Values During CSTs With ITT Peak 25ug ACTH stimulation test	0.70 correlation coefficient Interval 0.39 to 0.87	—
Pearson Correlation of Free Cortisol Values During CSTs With ITT 60- minute 250ug ACTH stimulation test	0.88 correlation coefficient Interval 0.74 to 0.95	—
Pearson Correlation of Free Cortisol Values During CSTs With ITT 30-minute 250ug ACTH stimulation test	0.89 correlation coefficient Interval 0.74 to 0.95	—

SECONDARY outcome

Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions

Peak total cortisol values during cortrosyn stimulation tests(CST)

Outcome measures

Outcome measures
Measure	Patients + Volunteers n=10 Participants Every participant underwent three ACTH stimulation test and one Insulin tolerance test.	Volunteers n=12 Participants Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test
Peak Total Cortisol Values Insulin Tolerance Test	23.3 ug/dl Interval 20.2 to 25.9	16.6 ug/dl Interval 1.1 to 26.1
Peak Total Cortisol Values 1 ug ACTH stimulation test	23.4 ug/dl Interval 16.7 to 31.9	14.5 ug/dl Interval 2.2 to 28.4
Peak Total Cortisol Values 25 ug ACTH stimulation test	22.0 ug/dl Interval 16.4 to 28.6	17.4 ug/dl Interval 2.0 to 24.9
Peak Total Cortisol Values 30 min 250 ug ACTH stimulation test	22.3 ug/dl Interval 18.8 to 27.8	16.1 ug/dl Interval 1.8 to 25.8
Peak Total Cortisol Values 60 min 250 ug ACTH simulation test	25.0 ug/dl Interval 21.9 to 31.5	19.1 ug/dl Interval 2.4 to 29.4

Adverse Events

1ug Cortrosyn Dose Stimulation Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

250 ug Cortrosyn Dose Stimulation Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

25 ug Cortrosyn Stimulation Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Tolerance Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Seenia Peechakara

Cleveland Clinic Foundation

Phone: 216 4105901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place