Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

This study has been completed.

Sponsor:

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

Tracking Information

First Received Date ^ICMJE

October 31, 2007

Last Updated Date

October 31, 2007

Start Date ^ICMJE

October 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

serum cortisol-peak 30 min after ACTH-stimulation [ Time Frame: 30 minutes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Official Title ^ICMJE

Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Hashimoto Disease
Adrenal Insufficiency

Intervention ^ICMJE

Drug: synacthen

1 µg synacthen in the vein

Other Name: ACTH

Study Arm (s)

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

Intervention: Drug: synacthen
2
patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test

Intervention: Drug: synacthen
3
patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test

Intervention: Drug: synacthen
4
patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test

Intervention: Drug: synacthen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00552487

Other Study ID Numbers ^ICMJE

112/05

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Wuerzburg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bruno Allolio, MD

University of Wuerzburg

Information Provided By

University of Wuerzburg

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top