Isolated ACTH Deficiency in Patients With Hashimoto Thyro... | NCT00552487

Studies
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

NCT00552487

Sponsor

University of Wuerzburg

Status

Completed

Last Update Posted

Nov 2, 2007Estimated

Enrollment

62Actual

Phase

Not Applicable

Conditions

Hashimoto Disease
Adrenal Insufficiency

Interventions

synacthen

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Oct 31, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
synacthen	Drug	1 µg synacthen in the vein	1 2 3 4

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Allolio, MD	University of Wuerzburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wuerzburg, Department of Endocrinology		Würzburg	Bavaria	97080	Germany

Condition Browse Module

MeSH Terms

ID	Term
D050031	Hashimoto Disease
D000309	Adrenal Insufficiency
C562707	ACTH Deficiency, Isolated
D013967	Thyroiditis, Autoimmune

Ancestor Terms

ID	Term
D013966	Thyroiditis
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C006418	adrenocorticotropin zinc
D000324	Adrenocorticotropic Hormone

Ancestor Terms

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided