Graves' Orbitopathy and Hypercholesterolemia

Completed

• Conditions: Graves' Ophthalmopathy; Hypercholesterolemia
• Interventions: Other: No intervention

• Registration Number: NCT02721992
• Lead Sponsor: University of Pisa

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Graves' disease with Graves' Orbitopathy
2. Graves' disease without Graves' Orbitopathy

Exclusion Criteria

1. Previous treatment with radioiodine
2. Previous treatment with thyroidectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Graves' Orbitopathy	No intervention	Patients with Graves' disease, with Graves' Orbitopathy
Graves' Disease	No intervention	Patients with Graves' disease, without Graves' Orbitopathy

Primary Outcome Measures

Name	Time	Method
Relationship between LDL cholesterol levels and Graves' Orbitopathy	Baseline	Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy

Secondary Outcome Measures

Name	Time	Method
Relationship between LDL cholesterol levels and the activity of Graves' Orbitopathy	Baseline	Relationship between the levels of LDL cholesterol and the Graves' Orbitopathy clinical activity score
Relationship between LDL cholesterol levels and the severity of Graves' Orbitopathy	Baseline	Relationship between the levels of LDL cholesterol the Graves' Orbitopathy severity score (NOSPECS score)

Trial Locations

Locations (1)

Ospedale Cisanello-Endocrinology I and II; 🇮🇹 Pisa, Italy