NCT01428336

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 23, 2017

Completed
Last Updated

July 25, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

September 1, 2011

Results QC Date

November 30, 2016

Last Update Submit

June 22, 2017

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

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

    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

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

Secondary Outcomes (2)

  • Pearson Correlation of Free Cortisol Values During CSTs With ITT

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

  • Peak Total Cortisol Values

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

Study Arms (2)

Patients

ACTIVE COMPARATOR

Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test

Procedure: 1 ug ACTH stimulation testProcedure: 250 ug ACTH stimulation testProcedure: 25 ug Cortrosyn stimulation testProcedure: Insulin tolerance test

Volunteers

ACTIVE COMPARATOR

Subjects will undergo three ACTH stimulation test using a dose of 1 ug cotrosyn, 25 ug cortrosyn, 250ug cortrosyn and one Insulin tolerance test

Procedure: 1 ug ACTH stimulation testProcedure: 250 ug ACTH stimulation testProcedure: 25 ug Cortrosyn stimulation testProcedure: Insulin tolerance test

Interventions

1 ug ACTH stimulation testPROCEDURE

1 ug cortrosyn dose

PatientsVolunteers
250 ug ACTH stimulation testPROCEDURE

ACTH stimulation test will be done using 250 ug cortrosyn dose

PatientsVolunteers
25 ug Cortrosyn stimulation testPROCEDURE

ACTH stimulation test using a 25 ug cortrosyn dose

PatientsVolunteers
Insulin tolerance testPROCEDURE

subjects will undergo an insulin tolerance test

PatientsVolunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypothalamic-pituitary-adrenal disorders

You may not qualify if:

  • under 18 or older than 65 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Department of Endocrinology

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Limitations and Caveats

Small number of participants Cortisol Binding globulin was not measured

Results Point of Contact

Title
Seenia Peechakara
Organization
Cleveland Clinic Foundation
peechas@ccf.org
216 4105901

Study Officials

  • Seenia Peechakara, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Every participant underwent the four interventional tests in random sequence
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 2, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 25, 2017

Results First Posted

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)