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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00552487
First Posted: November 2, 2007
Last Update Posted: November 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Wuerzburg
October 31, 2007
November 2, 2007
November 2, 2007
October 2005
Not Provided
serum cortisol-peak 30 min after ACTH-stimulation [ Time Frame: 30 minutes ]
Same as current
No Changes Posted
serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH [ Time Frame: 30 minutes ]
Same as current
Not Provided
Not Provided
 
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

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.

Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Hashimoto Disease
  • Adrenal Insufficiency
Drug: synacthen
1 µg synacthen in the vein
Other Name: ACTH
  • 1
    healthy people without Hashimoto disease receive a 1µg ACTH stimulation test
    Intervention: Drug: synacthen
  • 2
    patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test
    Intervention: Drug: synacthen
  • 3
    patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test
    Intervention: Drug: synacthen
  • 4
    patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test
    Intervention: Drug: synacthen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
July 2006
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00552487
112/05
Yes
Not Provided
Not Provided
Not Provided
University of Wuerzburg
Not Provided
Principal Investigator: Bruno Allolio, MD University of Wuerzburg
University of Wuerzburg
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP