Graves' Orbitopathy and Hypercholesterolemia (GOCol)

August 10, 2017 updated by: Marinò Michele, University of Pisa

A Prospective Study on the Association Between 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56124
        • Ospedale Cisanello-Endocrinology I and II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Graves' Disease
Patients with Graves' disease, without Graves' Orbitopathy
Other: No intervention
No intervention
Graves' Orbitopathy
Patients with Graves' disease, with Graves' Orbitopathy
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between LDL cholesterol levels and Graves' Orbitopathy
Time Frame: Baseline
Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOCol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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