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NCT02721992 Clinical Trial

Graves' Orbitopathy and Hypercholesterolemia

Hypercholesterolemia Clinical Trial

— GOCol  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02721992
Other study ID # GOCol
Secondary ID
Status Completed
Phase N/A
First received March 17, 2016
Last updated August 10, 2017
Start date January 2016
Est. completion date June 2017

Study information
Verified date August 2017
Source University of Pisa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
Italy Ospedale Cisanello-Endocrinology I and II Pisa

Sponsors (1)
Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relationship between LDL cholesterol levels and Graves' Orbitopathy Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy Baseline
Secondary Relationship between LDL cholesterol levels and the activity of Graves' Orbitopathy Relationship between the levels of LDL cholesterol and the Graves' Orbitopathy clinical activity score Baseline
Secondary Relationship between LDL cholesterol levels and the severity of Graves' Orbitopathy Relationship between the levels of LDL cholesterol the Graves' Orbitopathy severity score (NOSPECS score) Baseline
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