Hashimoto DiseaseNCT00552487
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
A study testing synacthen in people with Hashimoto Disease and Adrenal Insufficiency, run by University of Wuerzburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hashimoto Disease, Adrenal Insufficiency
- What is being tested?
- synacthen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent
Who cannot join
- • hypothyroidism of other origin
- pregnancy and lactation
- oral contraception
- glucocorticoid therapy during the last 2 months
- History of malignancy or chronic infections (Hepatitis, HIV)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Wuerzburg, Department of Endocrinology
Würzburg, Bavaria, 97080
About this study
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.
Read the 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.
- Conditions
- Hashimoto Disease, Adrenal Insufficiency
- Being tested
- synacthen
- Keywords
- isolated ACTH deficiency, Hashimoto disease, Hashimoto thyroiditis, autoimmune thyroiditis
- Medical subject headings
- Hashimoto Disease, Adrenal Insufficiency, ACTH Deficiency, Isolated, Thyroiditis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synacthenDrug
Also called ACTH
1 µg synacthen in the vein
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | healthy people without Hashimoto disease receive a 1µg ACTH stimulation test Receives: Drug: synacthen |
| 2 | Other | patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test Receives: Drug: synacthen |
| 3 | Other | patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test Receives: Drug: synacthen |
| 4 | Other | patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test Receives: Drug: synacthen |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cortisol-peak 30 min after ACTH-stimulation
Measured: 30 minutes
Secondary outcomes (1)
serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Allolio, MD, Principal investigator, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552487
- Sponsor's protocol ID
- 112/05
- Status last verified
- Oct 2007
- First submitted
- 31 Oct 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis
- ClinicalTrials.gov ID
- NCT00552487
- Acronym / sponsor ID
- 112/05
- Conditions
- Hashimoto Disease, Adrenal Insufficiency
- Keywords
- isolated ACTH deficiency, Hashimoto disease, Hashimoto thyroiditis, autoimmune thyroiditis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Jul 2006 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: synacthenhealthy people without Hashimoto disease receive a 1µg ACTH stimulation test |
| 2 | Other | Drug: synacthenpatients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test |
| 3 | Other | Drug: synacthenpatients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test |
| 4 | Other | Drug: synacthenpatients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent
Key exclusion criteria (5 listed)
- • hypothyroidism of other origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| synacthenAlso: ACTH1 µg synacthen in the vein | Drug | 1, 2, 3, 4 |
Primary outcome
serum cortisol-peak 30 min after ACTH-stimulation
Time frame: 30 minutes
1 secondary outcome
serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Allolio, MD principal investigator
University of Wuerzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synacthen in people with Hashimoto Disease and Adrenal Insufficiency, run by University of Wuerzburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cortisol-peak 30 min after ACTH-stimulation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2007; AzTrials last refreshed its copy on 1 Nov 2026.