CompletedNCT03498417IGF1RAbsGOUpdated Jul 30, 2018

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

An observational study in Graves Ophthalmopathy, Graves Disease and Autoimmune Thyroiditis, sponsored by University of Pisa. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-30.

Sponsored by University of Pisa · Observational

Study type: Observational
Model: Cohort
Time perspective: Cross-sectional
Enrollment: 135
Ages: 18 Years to 80 Years
Sex: All

Study 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 studied

Graves Ophthalmopathy
Graves Disease
Autoimmune Thyroiditis

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Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

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.
Patients with autoimmune thyroiditis
healthy subjects

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

Exclusion Criteria:

lack of informed consent

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Enrollment: 135 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

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

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

What researchers measure

Primary outcomes

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.
Time frame: Baseline

Secondary outcomes

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;
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03498417
Lead sponsor: University of Pisa
Responsible party: Marinò Michele (Assistant Professor, University of Pisa) — Principal investigator
First posted: Apr 13, 2018
Start date: Jun 20, 2018
Primary completion: Jul 20, 2018
Completion: Jul 20, 2018
Last update: Jul 30, 2018

Study contacts

Michele Marinò, MD

principal investigator · University of Pisa

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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