Mild Graves' Ophthalmopathy
Conditions
Brief 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. 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.
Interventions
DRUGMetformin
Tablets metformin 500 mg PO three times a day for 24 weeks
DRUGPlacebo
Tablets placebo PO three times a day for 24 weeks
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years 2. Patients should not have diabetes (HbA1c level at screening should be lower than 6.5) 3. Mild Graves' ophthalmopathy according to EUGOGO statement. 4. Clinical activity score lower than 4 5. Being euthyroid for at least 2 month before the enrollment 6. No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops)
Exclusion criteria
1. Moderate-severe Graves' ophthalmopathy 2. Clinical activity score ≥ 4 3. 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 4. Pregnant women 5. Current use of metformin or containing preparations 6. Metformin intolerance 7. Inability to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Clinical Activity Score (CAS) score | 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 | At 0, 6 and 12 months | Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | At 0, 6 and 12 months | Comparison of adverse events rate in each arm and an inter-arm. |
| Quality of life questionnaires (GO-QoL) | At 0, 6 and 12 months | Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm. |
Countries
South Korea
Contacts
Primary ContactEun Jig Lee, MD, PhD
Outcome results
None listed