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Completed

NCT Number: NCT03498417

Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies 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.

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Key information

Conditions

Graves Ophthalmopathy Autoimmune Diseases Autoimmune Thyroiditis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology Unit I, University of Pisa

Pisa, 56124, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum antibodies against the IGF-1R

Diagnostic Test

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

Primary outcomes

  1. Frequency of serum IGF-1R-Abs above the upper normal levels

    Time frame: 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 outcomes

  1. Serum concentrations of IGF-1R-Abs

    Time frame: 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;

  2. Relationship between serum IGF-1R-Abs and the activity of GO

    Time frame: 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

  3. Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies

    Time frame: Baseline

    The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyrotropic hormone-receptor serum autoantibodies

  4. Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies

    Time frame: Baseline

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

  5. Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies

    Time frame: Baseline

    The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroglobulin serum autoantibodies

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: IGF1RAbsGO

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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