Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy

Study Overview
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Brief Summary
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The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.

Official Title
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Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy

Conditions
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Graves Ophthalmopathy, Graves Disease, Autoimmune Thyroiditis

Intervention / Treatment
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* Diagnostic Test: Serum antibodies against the IGF-1R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R; for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination. for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases. For all subjects: Informed consent Exclusion Criteria: 1) lack of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Graves' diseases<br>Patients with Graves' disease. No interventions foreseen | Diagnostic Test: Serum antibodies against the IGF-1R<br>* Measurement of antibodies against the IGF-1R in serum samples by ELISA<br>|
| Autoimmune thyroiditis<br>Patients with autoimmune thyroiditis. No interventions foreseen | Diagnostic Test: Serum antibodies against the IGF-1R<br>* Measurement of antibodies against the IGF-1R in serum samples by ELISA<br>|
| Healthy Subjects<br>Normal healthy subjects. No interventions foreseen | Diagnostic Test: Serum antibodies against the IGF-1R<br>* Measurement of antibodies against the IGF-1R in serum samples by ELISA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of serum IGF-1R-Abs above the upper normal levels | Percent prevalence of serum IGF-1R-Abs above the upper normal levels in patients with GO, compared with healthy subjects, patients with Graves' disease without a clinically relevant GO, and patients with autoimmune thyroiditis. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of IGF-1R-Abs | Comparison of the serum concentrations of IGF-1R-Abs in patients with GO, compared with healthy subjects, patients with Graves' disease without GO, and patients with autoimmune thyroiditis; | Baseline | 
| Relationship between serum IGF-1R-Abs and the activity of GO | Relationship between serum IGF-1R-Abs (both levels and prevalence), with the the activity GO, namely the clinical activity score, including 7 items (spontaneous orbital pain, gaze provoked pain, palpebral redness, palpebral oedema, conjuctival redness, caruncle edema, chemosis) resulting in a score from 1 to 7 | Baseline | 
| Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies | The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyrotropic hormone-receptor serum autoantibodies | Baseline | 
| Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies | The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroperoxidase serum autoantibodies | Baseline | 
| Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies | The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroglobulin serum autoantibodies | Baseline |