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Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

NCT ID: NCT00552487

Last Updated: 2007-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hashimoto Disease Adrenal Insufficiency

Keywords

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isolated ACTH deficiency Hashimoto disease Hashimoto thyroiditis autoimmune thyroiditis

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

synacthen

Intervention Type DRUG

1 µg synacthen in the vein

2

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

Group Type OTHER

synacthen

Intervention Type DRUG

1 µg synacthen in the vein

3

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

Group Type OTHER

synacthen

Intervention Type DRUG

1 µg synacthen in the vein

4

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

Group Type OTHER

synacthen

Intervention Type DRUG

1 µg synacthen in the vein

Interventions

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synacthen

1 µg synacthen in the vein

Intervention Type DRUG

Other Intervention Names

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ACTH

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role lead

Principal Investigators

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Bruno Allolio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wuerzburg

Locations

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University of Wuerzburg, Department of Endocrinology

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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112/05

Identifier Type: -

Identifier Source: org_study_id