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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

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ClinicalTrials.gov Identifier: NCT00552487
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:
University of Wuerzburg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hashimoto Disease Adrenal Insufficiency Drug: synacthen Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Study Start Date : October 2005
Actual Study Completion Date : July 2006

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Arms and Interventions
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Arm Intervention/treatment
1
healthy people without Hashimoto disease receive a 1µg ACTH stimulation test
 Drug: synacthen
1 µg synacthen in the vein
Other Name: ACTH
2
patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test
 Drug: synacthen
1 µg synacthen in the vein
Other Name: ACTH
3
patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test
 Drug: synacthen
1 µg synacthen in the vein
Other Name: ACTH
4
patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test
 Drug: synacthen
1 µg synacthen in the vein
Other Name: ACTH


Outcome Measures
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Primary Outcome Measures :
  1. serum cortisol-peak 30 min after ACTH-stimulation [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH [ Time Frame: 30 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552487


Locations
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Germany
University of Wuerzburg, Department of Endocrinology
Wuerzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
Investigators
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Principal Investigator: Bruno Allolio, MD University of Wuerzburg
More Information
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ClinicalTrials.gov Identifier: NCT00552487    
Other Study ID Numbers: 112/05
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007
Keywords provided by University of Wuerzburg:
isolated ACTH deficiency
Hashimoto disease
Hashimoto thyroiditis
autoimmune thyroiditis
Additional relevant MeSH terms:
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Adrenal Insufficiency
Thyroiditis
Hashimoto Disease
Adrenal Gland Diseases
 Endocrine System Diseases
Thyroid Diseases
Thyroiditis, Autoimmune