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

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 |
- serum cortisol-peak 30 min after ACTH-stimulation [ Time Frame: 30 minutes ]
- serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH [ Time Frame: 30 minutes ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent
Exclusion Criteria:
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• hypothyroidism of other origin
- pregnancy and lactation
- oral contraception
- glucocorticoid therapy during the last 2 months
- History of malignancy or chronic infections (Hepatitis, HIV)

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
Germany | |
University of Wuerzburg, Department of Endocrinology | |
Wuerzburg, Bavaria, Germany, 97080 |
Principal Investigator: | Bruno Allolio, MD | University of Wuerzburg |
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 |
isolated ACTH deficiency Hashimoto disease Hashimoto thyroiditis autoimmune thyroiditis |
Adrenal Insufficiency Thyroiditis Hashimoto Disease Adrenal Gland Diseases |
Endocrine System Diseases Thyroid Diseases Thyroiditis, Autoimmune |