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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03498417

Acronym

IGF1RAbsGO

Enrollment

135

Registered

2018-04-13

Start date

2018-06-20

Completion date

2018-07-20

Last updated

2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Thyroiditis, Graves Disease, Graves Ophthalmopathy

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.

Interventions

DIAGNOSTIC_TESTSerum antibodies against the IGF-1R

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026