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NCT00552487 Clinical Trial

Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Adrenal Insufficiency Clinical Trial

Official title:
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00552487
Other study ID # 112/05
Secondary ID
Status Completed
Phase N/A
First received October 31, 2007
Last updated October 31, 2007
Start date October 2005
Est. completion date July 2006

Study information
Verified date October 2007
Source University of Wuerzburg
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• synacthen
1 µg synacthen in the vein

Locations
Country Name City State
Germany University of Wuerzburg, Department of Endocrinology Wuerzburg Bavaria

Sponsors (1)
Lead Sponsor Collaborator
University of Wuerzburg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum cortisol-peak 30 min after ACTH-stimulation 30 minutes
Secondary serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH 30 minutes
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