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Trial record 112 of 117 for:    "Graves Disease"

Graves' Orbitopathy and Hypercholesterolemia (GOCol)

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ClinicalTrials.gov Identifier: NCT02721992
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Marinò Michele, 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

Condition or disease Intervention/treatment
Graves' Ophthalmopathy Hypercholesterolemia Other: No intervention

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Prospective Study on the Association Between Graves' Orbitopathy and Hypercholesterolemia
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721992


Locations
Italy
Ospedale Cisanello-Endocrinology I and II
Pisa, Italy, 56124
Sponsors and Collaborators
University of Pisa

Responsible Party: Marinò Michele, Ricercatore (Assistant Professor), University of Pisa
ClinicalTrials.gov Identifier: NCT02721992     History of Changes
Other Study ID Numbers: GOCol
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Graves Disease
Hypercholesterolemia
Eye Diseases
Graves Ophthalmopathy
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Eye Diseases, Hereditary
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases