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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

This study has been completed.
Sponsor:
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00552487
First received: October 31, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Resource links provided by NLM:

U.S. FDA Resources

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00552487     History of Changes
Other Study ID Numbers: 112/05
Study First Received: October 31, 2007
Last Updated: October 31, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Wuerzburg:
isolated ACTH deficiency
Hashimoto disease
Hashimoto thyroiditis
autoimmune thyroiditis

Additional relevant MeSH terms:
Adrenal Insufficiency
Hashimoto Disease
Thyroiditis
Adrenal Gland Diseases
 Endocrine System Diseases
Thyroid Diseases
Thyroiditis, Autoimmune

ClinicalTrials.gov processed this record on March 03, 2015