Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis - Full Text View

Sponsor:	University of Wuerzburg
Information provided by:	University of Wuerzburg
ClinicalTrials.gov Identifier:	NCT00552487

Purpose

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	Intervention
Hashimoto Disease Adrenal Insufficiency	Drug: synacthen

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Parallel Assignment
Official Title:	Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked adrenoleukodystrophy

U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	62
Study Start Date:	October 2005
Study Completion Date:	July 2006

Arms	Assigned Interventions
1 healthy people without Hashimoto disease receive a 1µg ACTH stimulation test	Drug: synacthen 1 µg synacthen in the vein
2 patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test	Drug: synacthen 1 µg synacthen in the vein
3 patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test	Drug: synacthen 1 µg synacthen in the vein
4 patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test	Drug: synacthen 1 µg synacthen in the vein

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552487

Locations

Germany, Bavaria
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

More Information

No publications provided

Study ID Numbers:	112/05
Study First Received:	October 31, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00552487 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Wuerzburg:

isolated ACTH deficiency
Hashimoto disease
Hashimoto thyroiditis
autoimmune thyroiditis

Additional relevant MeSH terms:

Hashimoto Disease
Hypothalamic Diseases
Adrenal Insufficiency
Autoimmune Diseases
Pituitary Diseases
Immune System Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Diseases

Adrenal Gland Diseases
Endocrine System Diseases
Brain Diseases
Hormones
Thyroiditis
Pharmacologic Actions
Adrenocorticotropic Hormone
Addison Disease
Thyroiditis, Autoimmune
Thyroid Diseases

ClinicalTrials.gov processed this record on November 25, 2009