Mild Graves' OphthalmopathyNCT02535975
The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
A study testing Metformin in people with Mild Graves' Ophthalmopathy, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild ophthalmopathy will be included. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Graves' Ophthalmopathy
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Oct 2019
- Phase
- Interventional
- 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
Who may be able to join
- Age 18-80 years
- Patients should not have diabetes (HbA1c level at screening should be lower than 6.5)
- Mild Graves' ophthalmopathy according to EUGOGO statement.
- Clinical activity score lower than 4
- Being euthyroid for at least 2 month before the enrollment
- No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops)
Who cannot join
- Moderate-severe Graves' ophthalmopathy
- Clinical activity score ≥ 4
- Contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (AST and ALT levels should be within normal range), severe concomitant illness
- Pregnant women
- Current use of metformin or containing preparations
- Metformin intolerance
- Inability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Endocrinology, Internal Medicine, Yonsei University College of Medicine
Seoul, 03722
Eun Jig Lee, MD, +82-2-2228-1983, ejlee432@yuhs.ac
About this study
This is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months after withdrawal of treatment.
- Conditions
- Mild Graves' Ophthalmopathy
- Being tested
- Metformin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Tablets metformin 500 mg PO three times a day for 24 weeks
PlaceboDrug
Tablets placebo PO three times a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin 500mg PO three times a day for 24 weeks Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo tab. PO three times a day for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Clinical Activity Score (CAS) score
Comparison of CAS scores before and after treatment in each arm and an inter-arm
Measured: At 0, 6 and 12 months
Change of NOSPECS score
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.
Measured: At 0, 6 and 12 months
Secondary outcomes (2)
adverse events
Comparison of adverse events rate in each arm and an inter-arm.
Measured: At 0, 6 and 12 months
Quality of life questionnaires (GO-QoL)
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm.
Measured: At 0, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Graves' OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535975
- Sponsor's protocol ID
- 4-2014-0706
- Status last verified
- Jan 2019
- First submitted
- 12 Aug 2015
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
- ClinicalTrials.gov ID
- NCT02535975
- Acronym / sponsor ID
- 4-2014-0706
- Conditions
- Mild Graves' Ophthalmopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 31 Aug 2015 (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.
This is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months after withdrawal of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin 500mg PO three times a day for 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tab. PO three times a day for 24 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years
- Patients should not have diabetes (HbA1c level at screening should be lower than 6.5)
- Mild Graves' ophthalmopathy according to EUGOGO statement.
- Clinical activity score lower than 4
- Being euthyroid for at least 2 month before the enrollment
Key exclusion criteria (7 listed)
- Moderate-severe Graves' ophthalmopathy
- Clinical activity score ≥ 4
- Contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (AST and ALT levels should be within normal range), severe concomitant illness
- Pregnant women
- Current use of metformin or containing preparations
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 |
|---|---|---|
| MetforminTablets metformin 500 mg PO three times a day for 24 weeks | Drug | Metformin |
| PlaceboTablets placebo PO three times a day for 24 weeks | Drug | Placebo |
Primary outcome
Change of Clinical Activity Score (CAS) score
Time frame: At 0, 6 and 12 months
Comparison of CAS scores before and after treatment in each arm and an inter-arm
Change of NOSPECS score
Time frame: At 0, 6 and 12 months
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.
2 secondary outcomes
adverse events
Time frame: At 0, 6 and 12 months
Quality of life questionnaires (GO-QoL)
Time frame: At 0, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Related trials for Mild Graves' Ophthalmopathy
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Graves Ophthalmopathy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin in people with Mild Graves' Ophthalmopathy, run by Yonsei University at 1 site in South Korea.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jan 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Jig Lee, MD, PhD (+82-2-2228-1983, ejlee432@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clinical Activity Score (CAS) score (time frame: At 0, 6 and 12 months). The study lists 2 primary outcomes in all. 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 30 Jan 2019.