Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy (IGF1RAbsGO)

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

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 Overview

• Status: Completed
• Conditions: Graves Ophthalmopathy; Graves Disease; Autoimmune Thyroiditis
• Intervention / Treatment: Diagnostic test: Serum antibodies against the IGF-1R

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56124
    • Endocrinology Unit I, University of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Patients with Graves' disease, with or without GO. The presence of GO will be established in any patient who had at least one of the following eye features: a) exophthalmometry ≥17 mm in women and ≥19 mm in men, based on measurements conducted for the normal population; b) eyelid aperture ≥9 mm; c) clinical activity score ≥1/7; iv) presence of diplopia; v) presence of corneal alterations; vi) presence of GO-related alterations of the fundi; and vii) reduction in visual acuity that could be attributed to GO.
2. Patients with autoimmune thyroiditis
3. healthy subjects

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Principal Investigator: Michele Marinò, MD, University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): July 20, 2018

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy; Hashimoto Disease; Graves Disease; Thyroiditis; Thyroiditis, Autoimmune; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: IGF1-R-Abs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No