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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
  Purpose
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 Intervention
Hashimoto Disease Adrenal Insufficiency Drug: synacthen

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

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

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

Enrollment: 62
Study Start Date: October 2005
Study Completion Date: July 2006
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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
Germany
University of Wuerzburg, Department of Endocrinology
Wuerzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
University of Wuerzburg
Investigators
Principal Investigator: Bruno Allolio, MD University of Wuerzburg
  More Information

ClinicalTrials.gov Identifier: NCT00552487     History of Changes
Other Study ID Numbers: 112/05
First Submitted: October 31, 2007
First Posted: November 2, 2007
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:
Adrenal Insufficiency
Thyroiditis
Hashimoto Disease
Endocrine System Diseases
Hypoglycemia
Genetic Diseases, Inborn
Adrenal Gland Diseases
Thyroid Diseases
Thyroiditis, Autoimmune
Glucose Metabolism Disorders
Metabolic Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs