NCT00552487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
Last Updated

November 2, 2007

Status Verified

October 1, 2007

First QC Date

October 31, 2007

Last Update Submit

October 31, 2007

Conditions

Hashimoto DiseaseAdrenal Insufficiency

Keywords

isolated ACTH deficiencyHashimoto diseaseHashimoto thyroiditisautoimmune thyroiditis

Outcome Measures

Primary Outcomes (1)

  • serum cortisol-peak 30 min after ACTH-stimulation

    30 minutes

Secondary Outcomes (1)

  • serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH

    30 minutes

Study Arms (4)

1

OTHER

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

Drug: synacthen

2

OTHER

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

Drug: synacthen

3

OTHER

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

Drug: synacthen

4

OTHER

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

Drug: synacthen

Interventions

synacthenDRUG

1 µg synacthen in the vein

Also known as: ACTH
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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent

You may not qualify if:

  • hypothyroidism of other origin
  • pregnancy and lactation
  • oral contraception
  • glucocorticoid therapy during the last 2 months
  • History of malignancy or chronic infections (Hepatitis, HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wuerzburg, Department of Endocrinology

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Hashimoto DiseaseAdrenal InsufficiencyACTH Deficiency, IsolatedThyroiditis, Autoimmune

Interventions

adrenocorticotropin zincAdrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

ThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAdrenal Gland Diseases

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Bruno Allolio, MD

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

October 1, 2005

Study Completion

July 1, 2006

Last Updated

November 2, 2007

Record last verified: 2007-10

Locations

DE(1)