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

Completed

• Conditions: Graves Ophthalmopathy; Graves Disease; Autoimmune Thyroiditis
• Interventions: Diagnostic Test: Serum antibodies against the IGF-1R

• Registration Number: NCT03498417
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Study Start: 2018-06-20
• Status Verified: 2018-07
• Primary Completion: 2018-07-20
• Study Completion: 2018-07-20
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Graves' diseases	Serum antibodies against the IGF-1R	Patients with Graves' disease. No interventions foreseen
Autoimmune thyroiditis	Serum antibodies against the IGF-1R	Patients with autoimmune thyroiditis. No interventions foreseen
Healthy Subjects	Serum antibodies against the IGF-1R	Normal healthy subjects. No interventions foreseen

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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 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-thyroperoxidase autoantibodies	Baseline	The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroperoxidase serum autoantibodies

Trial Locations

Locations (1)

Endocrinology Unit I, University of Pisa; 🇮🇹 Pisa, Italy