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Completed

NCT Number: NCT02721992

Graves' Orbitopathy and Hypercholesterolemia

The investigators have recently observed retrospectively that the occurrence of Graves' Orbitopathy in patients with Graves' disease is less frequent in patients with normal cholesterol levels, in line with another recent observation suggesting that statins play a protective role in Graves' patients from developing Graves' Orbitopathy. The present study is designed in order to investigate the possible association between Graves' Orbitopathy and high cholesterol level as well as the relation between Graves' Orbitopathy degree and high cholesterol level

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Key information

Conditions

Graves' Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hypercholesterolemia Hyperlipidemias Hyperthyroidism Immune System Diseases Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Cisanello-Endocrinology I and II

Pisa, 56124, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Graves' disease with Graves' Orbitopathy
  • Graves' disease without Graves' Orbitopathy

Exclusion criteria

  • Previous treatment with radioiodine
  • Previous treatment with thyroidectomy

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Relationship between LDL cholesterol levels and Graves' Orbitopathy

    Time frame: Baseline

    Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy

Secondary outcomes

  1. Relationship between LDL cholesterol levels and the activity of Graves' Orbitopathy

    Time frame: Baseline

    Relationship between the levels of LDL cholesterol and the Graves' Orbitopathy clinical activity score

  2. Relationship between LDL cholesterol levels and the severity of Graves' Orbitopathy

    Time frame: Baseline

    Relationship between the levels of LDL cholesterol the Graves' Orbitopathy severity score (NOSPECS score)

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

A Prospective Study on the Association Between Graves' Orbitopathy and Hypercholesterolemia

Acronym: GOCol

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
Aug 14, 2017

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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