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

University of Pisa135 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Graves Ophthalmopathy Graves Disease Autoimmune Thyroiditis

Interventions

Serum antibodies against the IGF-1RDIAGNOSTIC_TEST

Measurement of antibodies against the IGF-1R in serum samples by ELISA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R; 2. 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. 3. 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

Locations (1)

Endocrinology Unit I, University of Pisa

Pisa, Italy

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

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;

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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