The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
Overview
- Phase
- Not Applicable
- Intervention
- Metformin
- Conditions
- Mild Graves' Ophthalmopathy
- Sponsor
- Yonsei University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change of NOSPECS score
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Metformin
Metformin 500mg PO three times a day for 24 weeks
Intervention: Metformin
Placebo
Placebo tab. PO three times a day for 24 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
- Quality of life questionnaires (GO-QoL)(At 0, 6 and 12 months)
- adverse events(At 0, 6 and 12 months)