Graves' OphthalmopathyGOColNCT02721992
Graves' Orbitopathy and Hypercholesterolemia
An observational study of Graves' Ophthalmopathy and Hypercholesterolemia, run by University of Pisa at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Graves' Ophthalmopathy, Hypercholesterolemia
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with Graves' disease, with or without Graves' Orbitopathy, off methimazole since two days to perform radioiodine treatment
Who may be able to join
- Graves' disease with Graves' Orbitopathy
- Graves' disease without Graves' Orbitopathy
Who cannot join
- Previous treatment with radioiodine
- Previous treatment with thyroidectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Graves' Ophthalmopathy, Hypercholesterolemia
- Being tested
- No intervention
- Medical subject headings
- Graves Ophthalmopathy, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Graves' Disease | Patients with Graves' disease, without Graves' Orbitopathy Receives: Other: No intervention | |
| Graves' Orbitopathy | Patients with Graves' disease, with Graves' Orbitopathy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between LDL cholesterol levels and Graves' Orbitopathy
Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy
Measured: Baseline
Secondary outcomes (2)
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
Measured: Baseline
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marinò Michele, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721992
- Sponsor's protocol ID
- GOCol
- Acronym
- GOCol
- Status last verified
- Aug 2017
- First submitted
- 17 Mar 2016
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Association Between Graves' Orbitopathy and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT02721992
- Acronym / sponsor ID
- GOCol / GOCol
- Conditions
- Graves' Ophthalmopathy, Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graves' Disease | – | Other: No interventionPatients with Graves' disease, without Graves' Orbitopathy |
| Graves' Orbitopathy | – | Other: No interventionPatients with Graves' disease, with Graves' Orbitopathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with Graves' disease, with or without Graves' Orbitopathy, off methimazole since two days to perform radioiodine treatment
Key inclusion criteria (2 listed)
- Graves' disease with Graves' Orbitopathy
- Graves' disease without Graves' Orbitopathy
Key exclusion criteria (2 listed)
- Previous treatment with radioiodine
- Previous treatment with thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Graves' Disease, Graves' Orbitopathy |
Primary outcome
Relationship between LDL cholesterol levels and Graves' Orbitopathy
Time frame: Baseline
Relationship between the levels of LDL cholesterol and the presence of Graves' Orbitopathy
2 secondary outcomes
Relationship between LDL cholesterol levels and the activity of Graves' Orbitopathy
Time frame: Baseline
Relationship between LDL cholesterol levels and the severity of Graves' Orbitopathy
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves' Ophthalmopathy and Hypercholesterolemia, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between LDL cholesterol levels and Graves' Orbitopathy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.