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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin 500mg PO three times a day for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo tab. PO three times a day for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Tablets metformin 500 mg PO three times a day for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Clinical Activity Score (CAS) score | Comparison of CAS scores before and after treatment in each arm and an inter-arm | 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. | At 0, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Comparison of adverse events rate in each arm and an inter-arm. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Jig Lee, MD, PhD | Contact | +82-2-2228-1983 | ejlee432@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology, Internal Medicine, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Tablets placebo PO three times a day for 24 weeks |
|
| At 0, 6 and 12 months |