IGF1RAbsGO: Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Graves' diseases Patients with Graves' disease. No interventions foreseen |
Diagnostic Test: Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA
|
| Autoimmune thyroiditis Patients with autoimmune thyroiditis. No interventions foreseen |
Diagnostic Test: Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA
|
| Healthy Subjects Normal healthy subjects. No interventions foreseen |
Diagnostic Test: Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA
|
Outcome Measures
Primary Outcome Measures
- Frequency of serum IGF-1R-Abs above the upper normal levels [Baseline]
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.
Secondary Outcome Measures
- Serum concentrations of IGF-1R-Abs [Baseline]
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;
- Relationship between serum IGF-1R-Abs and the activity of GO [Baseline]
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
- Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies [Baseline]
The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyrotropic hormone-receptor serum autoantibodies
- Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies [Baseline]
The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroperoxidase serum autoantibodies
- Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies [Baseline]
The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroglobulin serum autoantibodies
Eligibility Criteria
Criteria
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:
- lack of informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endocrinology Unit I, University of Pisa | Pisa | Italy | 56124 |
Sponsors and Collaborators
- University of Pisa
Investigators
- Principal Investigator: Michele Marinò, MD, University of Pisa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IGF1-R-Abs