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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Parallel Assignment

Official Title:	Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

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

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

Keywords provided by University of Wuerzburg:

isolated ACTH deficiency

Hashimoto disease

Hashimoto thyroiditis

autoimmune thyroiditis

Study placed in the following topic categories:

Hashimoto Disease

Hypothalamic Diseases

Lymphomatous thyroiditis

Adrenal Insufficiency

Pituitary Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Central Nervous System Diseases

Brain Diseases

Hypoadrenalism

Thyroiditis

Adrenal gland hypofunction

ACTH deficiency

Hashimoto's syndrome

Thyroiditis, Autoimmune

Endocrinopathy

Thyroid Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 07, 2008

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