Evaluation of Thyroid Function in Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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A higher prevalence of thyroid disease has been associated with chronic kidney disease (CKD), and subclinical hypothyroidism seems to be the most common dysfunction. The aim is to evaluate thyroid function and autoimmunity in patients with CKD stages 3, 4 and 5. Cross-sectional study to be carried out on patients with stages 3 and 4 in a Nephrology outpatient clinic. Thyroid function is evaluated by measuring thyroid stimulating hormone (TSH), free thyroxine, free triiodothyronine and antithyroperoxidase antibodies (TPOAb) levels.

Detailed Description
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Cross-sectional study to be carried out on patients with stages 3, 4 and 5 in a Nephrology outpatient clinic. Thyroid function is evaluated by measuring thyroid stimulating hormone (TSH), free thyroxine, free triiodothyronine and antithyroperoxidase antibodies (TPOAb) levels. Free Thyroxine (FT4) will be measured by liquid chromatography tandem mass spectrometry and electrochemiluminescence immunoassay in order to compare methods in this population. The glomerular filtration rate was estimated (eGFR) by the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI), and the CKD stages were defined according to the Kidney Disease Improving Global Outcomes directives (KDIGO).

Official Title
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Evaluation of Thyroid Function in Patients With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease, Thyroid Dysfunction

Intervention / Treatment
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* Diagnostic Test: Thyroid function


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients over 18 years old with CKD stages 3 and 4 were included in the study. - Exclusion Criteria: 1) acute systemic inflammatory disease; 2) pituitary disease in the past or present; 3) regular treatment with amiodarone, lithium, interferon, immunosuppressive drugs and glucocorticoids; 4) previously diagnosed hypothyroidism and undergoing levothyroxine replacement. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chonic kidney disease stages 3, 4 and 5<br>Patients with stage chronic kidney disease stages 3, 4 and 5. CKD stages were defined according to the Kidney Disease Improving Global Outcomes directives (KDIGO): a) stage 3A: eGFR 45 and 59 ml/min/1.73m2; b) stage 3B: eGFR between 30 and 44 ml/min/1.73m2; c) stage 4: eGFR between 15 and 29 ml/min/1.73 m2 | Diagnostic Test: Thyroid function<br>* laboratorial thyroid tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free thyroxine (FT4) levels in chronic kidney disease | Free thyroxine levels through two different methods | through study completion, an average of 3 years | 
| TSH levels in chronic kidney disease | TSH levels | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of thyroid antibodies in chronic kidney disease | antithyroperoxidase and antitireoglobulin antibodies | through study completion, an average of 3 years | 
| Free triiodothyronine (FT3) levels in chronic kidney disease | T3 levels | through study completion, an average of 3 years |