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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Endocrinology, Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGChange of Clinical Activity Score (CAS) score
Comparison of CAS scores before and after treatment in each arm and an inter-arm
Time frame: 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.
Time frame: At 0, 6 and 12 months
adverse events
Comparison of adverse events rate in each arm and an inter-arm.
Time frame: 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.
Time frame: At 0, 6 and 12 months
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