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Isolated 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
University of Wuerzburg
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 31, 2007
Last Updated
October 31, 2007
Sponsor
University of Wuerzburg
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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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