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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01884649
Other study ID # GEAH-1
Secondary ID
Status Completed
Phase N/A
First received June 17, 2013
Last updated June 21, 2013
Start date May 2012
Est. completion date October 2012

Study information

Verified date June 2013
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients newly diagnosed with Hashimoto thyroiditis

Exclusion Criteria:

- 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

- Endocrine disorders

- Malignancy

- Usage of drug that affects thyroid hormone levels

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of serum fetuin A levels between patients with Hashimoto thyroiditis and healthy subjects 1 day (The blood samples were obtained on the same day participants arrived to outpatient clinics.) No
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