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

NCT03498417 | Completed

• 1 other identifier: IGF1-R-Abs
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Graves Ophthalmopathy; Graves Disease; Autoimmune Thyroiditis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Serum concentrations of IGF-1R-Abs

  Baseline

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

  Baseline

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

  Baseline

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

  Baseline

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

  Baseline

Study Arms (3)

Graves' diseases

Patients with Graves' disease. No interventions foreseen

Diagnostic Test: Serum antibodies against the IGF-1R

Autoimmune thyroiditis

Patients with autoimmune thyroiditis. No interventions foreseen

Diagnostic Test: Serum antibodies against the IGF-1R

Healthy Subjects

Normal healthy subjects. No interventions foreseen

Diagnostic Test: Serum antibodies against the IGF-1R

Interventions

Serum antibodies against the IGF-1R DIAGNOSTIC_TEST

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

Autoimmune thyroiditis; Graves' diseases; Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \) lack of informed consent

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

Endocrinology Unit I, University of Pisa

Pisa, 56124, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Graves Ophthalmopathy; Graves Disease; Thyroiditis, Autoimmune

Condition Hierarchy (Ancestors)

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

Study Officials

• Michele Marinò, MD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 13, 2018
• Study Start: June 20, 2018
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)