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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
This study has been completed.
Sponsor:
University of Wuerzburg
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
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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:
Genetic and Rare Diseases Information Center resources:
Hypoadrenalism
Lymphomatous Thyroiditis
Isolated ACTH Deficiency
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 (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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00552487
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
| ClinicalTrials.gov Identifier: | NCT00552487 History of Changes |
| Other Study ID Numbers: |
112/05 |
| Study First Received: | October 31, 2007 |
| Last Updated: | October 31, 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 |
ClinicalTrials.gov processed this record on June 27, 2017