Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

October 31, 2007 updated by: University of Wuerzburg
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Wuerzburg, Bavaria, Germany, 97080
        • University of Wuerzburg, Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum cortisol-peak 30 min after ACTH-stimulation
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wuerzburg

Investigators

  • Principal Investigator: Bruno Allolio, MD, University of Wuerzburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 31, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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