Graves' Orbitopathy and Hypercholesterolemia

NCT02721992 | Completed

• 1 other identifier: GOCol
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Graves' Ophthalmopathy; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Relationship between LDL cholesterol levels and Graves' Orbitopathy

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

  Baseline

Secondary Outcomes (2)

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

  Baseline

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

  Baseline

Study Arms (2)

Graves' Disease

Patients with Graves' disease, without Graves' Orbitopathy

Other: No intervention

Graves' Orbitopathy

Patients with Graves' disease, with Graves' Orbitopathy

Other: No intervention

Interventions

No intervention OTHER

No intervention

Graves' Disease; Graves' Orbitopathy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with Graves' disease, with or without Graves' Orbitopathy, off methimazole since two days to perform radioiodine treatment

You may qualify if:

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

You may not qualify if:

• Previous treatment with radioiodine
• Previous treatment with thyroidectomy

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

Ospedale Cisanello-Endocrinology I and II

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; 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; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

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

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 29, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)