Hashimoto ThyroiditisNCT01884649
Fetuin A in Hashimoto Thyroiditis
An observational study of Hashimoto Thyroiditis, run by Istanbul Medeniyet University.
Trial summary
Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this study, we hypothesised that the serum fetuin A levels could be found to be low due to inflammation in patients with Hashimoto thyroiditis Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hashimoto Thyroiditis
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Oct 2012
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the below mentioned criteria were included in the study
Who may be able to join
- patients newly diagnosed with Hashimoto thyroiditis
Who cannot join
- Acute infection
- Acute or chronic inflammatory disease
- Anti-inflammatory treatment (non-steroidal anti-inflammatory, corticosteroids etc.)
- Hypoxic situations (chronic obstructive pulmonary disease etc.)
- Severe heart, kidney and liver disease
- Pregnancy
Show all 9Show fewer
- Endocrine disorders
- Malignancy
- Usage of drug that affects thyroid hormone levels
About this study
Official title: Fetuin A as a New Marker of Inflammation in Hashimoto Thyroiditis
Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this study, we hypothesised that the serum fetuin A levels could be found to be low due to inflammation in patients with Hashimoto thyroiditis
Read the detailed description
Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the eligibility criteria will be included in the study. Approval of the local ethics committee and informed consent of the participants will be received for the study. The study is conducted in accordance with the Declaration of Helsinki. Demographic characteristics, concomitant diseases, smoking and alcohol drinking habits, concomitant medication usage, anthropometric and biochemistry data of the eligible patients will be recorded. Patient group will consist of patients with newly diagnosed Hashimoto thyroiditis and the control group will consist of healthy volunteers.
Groups will be compared according to their demographic, an¬thropometric and biochemistry data and serum fetuin-A levels. In order to detect the relationship between the serum fetuin-A levels and clinical features, correlation analyses will be done.
- Conditions
- Hashimoto Thyroiditis
- Keywords
- Acute phase reactant, fetuin A, Hashimoto thyroiditis
- Medical subject headings
- Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group of Hashimoto thyroiditis patients | Not described | |
| Healty control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum fetuin A levels between patients with Hashimoto thyroiditis and healthy subjects
Measured: 1 day (The blood samples were obtained on the same day participants arrived to outpatient clinics.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto ThyroiditisStudies 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevilay Muratli, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884649
- Sponsor's protocol ID
- GEAH-1
- Status last verified
- Jun 2013
- First submitted
- 17 Jun 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetuin A as a New Marker of Inflammation in Hashimoto Thyroiditis
- ClinicalTrials.gov ID
- NCT01884649
- Acronym / sponsor ID
- GEAH-1
- Conditions
- Hashimoto Thyroiditis
- Keywords
- Acute phase reactant, fetuin A, Hashimoto thyroiditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 24 Jun 2013 (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.
Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this study, we hypothesised that the serum fetuin A levels could be found to be low due to inflammation in patients with Hashimoto thyroiditis
Detailed description
Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the eligibility criteria will be included in the study. Approval of the local ethics committee and informed consent of the participants will be received for the study. The study is conducted in accordance with the Declaration of Helsinki. Demographic characteristics, concomitant diseases, smoking and alcohol drinking habits, concomitant medication usage, anthropometric and biochemistry data of the eligible patients will be recorded. Patient group will consist of patients with newly diagnosed Hashimoto thyroiditis and the control group will consist of healthy volunteers.
Groups will be compared according to their demographic, an¬thropometric and biochemistry data and serum fetuin-A levels. In order to detect the relationship between the serum fetuin-A levels and clinical features, correlation analyses will be done.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Hashimoto thyroiditis patients | – | – |
| Healty control group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the below mentioned criteria were included in the study
Key inclusion criteria (1 listed)
- patients newly diagnosed with Hashimoto thyroiditis
Key exclusion criteria (9 listed)
- Acute infection
- Acute or chronic inflammatory disease
- Anti-inflammatory treatment (non-steroidal anti-inflammatory, corticosteroids etc.)
- Hypoxic situations (chronic obstructive pulmonary disease etc.)
- Severe heart, kidney and liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of serum fetuin A levels between patients with Hashimoto thyroiditis and healthy subjects
Time frame: 1 day (The blood samples were obtained on the same day participants arrived to outpatient clinics.)
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 24 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hashimoto Thyroiditis, run by Istanbul Medeniyet University.
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 9 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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of serum fetuin A levels between patients with Hashimoto thyroiditis and healthy subjects (time frame: 1 day (The blood samples were obtained on the same day participants arrived to outpatient clinics.)). 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 24 Jun 2013.