Back to resultsIsolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Primary Purpose
Hashimoto Disease, Adrenal Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
synacthen
Sponsored by
About this trial
This is an interventional diagnostic trial for Hashimoto Disease focused on measuring isolated ACTH deficiency, Hashimoto disease, Hashimoto thyroiditis, autoimmune thyroiditis
Eligibility Criteria
Inclusion Criteria:
- Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent
Exclusion Criteria:
• hypothyroidism of other origin
- pregnancy and lactation
- oral contraception
- glucocorticoid therapy during the last 2 months
- History of malignancy or chronic infections (Hepatitis, HIV)
Sites / Locations
- University of Wuerzburg, Department of Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
1
2
3
4
Arm Description
healthy people without Hashimoto disease receive a 1µg ACTH stimulation test
patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test
patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test
patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test
Outcomes
Primary Outcome Measures
serum cortisol-peak 30 min after ACTH-stimulation
Secondary Outcome Measures
serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH
Full Information
NCT ID
NCT00552487
First Posted
October 31, 2007
Last Updated
October 31, 2007
Sponsor
University of Wuerzburg
1. Study Identification
Unique Protocol Identification Number
NCT00552487
Brief Title
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Official Title
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Wuerzburg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.
Detailed Description
Many patients with Hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated ACTH deficiency was found.
In this study a 1 µg ACTH test is performed to evaluate the adrenocortical function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hashimoto Disease, Adrenal Insufficiency
Keywords
isolated ACTH deficiency, Hashimoto disease, Hashimoto thyroiditis, autoimmune thyroiditis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
healthy people without Hashimoto disease receive a 1µg ACTH stimulation test
Arm Title
2
Arm Type
Other
Arm Description
patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test
Arm Title
3
Arm Type
Other
Arm Description
patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test
Arm Title
4
Arm Type
Other
Arm Description
patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test
Intervention Type
Drug
Intervention Name(s)
synacthen
Other Intervention Name(s)
ACTH
Intervention Description
1 µg synacthen in the vein
Primary Outcome Measure Information:
Title
serum cortisol-peak 30 min after ACTH-stimulation
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent
Exclusion Criteria:
• hypothyroidism of other origin
pregnancy and lactation
oral contraception
glucocorticoid therapy during the last 2 months
History of malignancy or chronic infections (Hepatitis, HIV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Allolio, MD
Organizational Affiliation
University of Wuerzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wuerzburg, Department of Endocrinology
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
12. IPD Sharing Statement
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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
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