Clincosm LogoSign in Get a demo

Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Sponsor
University of Wuerzburg (Other)
Overall Status
Completed
CT.gov ID
NCT00552487
Collaborator
(none)
62
Enrollment
1
Location
4
Arms
9
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
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 :
Oct 1, 2005
Actual Study Completion Date :
Jul 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Other: 1

healthy people without Hashimoto disease receive a 1µg ACTH stimulation test

Drug: synacthen
1 µg synacthen in the vein
Other Names:
  • ACTH

    		•
    Other: 2

    patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test

    Drug: synacthen
    1 µg synacthen in the vein
    Other Names:
  • ACTH

    		•
    Other: 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 Names:
  • ACTH

    		•
    Other: 4

    patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test

    Drug: synacthen
    1 µg synacthen in the vein
    Other Names:
  • ACTH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. serum cortisol-peak 30 min after ACTH-stimulation [30 minutes]

    Secondary Outcome Measures

    1. serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH [30 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00552487
    Other Study ID Numbers:
    • 112/05
    First Posted:
    Nov 2, 2007
    Last Update Posted:
    Nov 2, 2007
    Last Verified:
    Oct 1, 2007
    Keywords provided by , ,
    isolated ACTH deficiency
    Hashimoto disease
    Hashimoto thyroiditis
    autoimmune thyroiditis
    Additional relevant MeSH terms:
    Adrenal Insufficiency
    Thyroiditis
    Hashimoto Disease

    Study Results

    No Results Posted as of Nov 2, 2007