The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of NOSPECS score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Metformin
Metformin 500mg PO three times a day for 24 weeks
干预措施: Metformin (Drug)
Placebo
Placebo tab. PO three times a day for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change of NOSPECS score
时间窗: 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
时间窗: At 0, 6 and 12 months
Comparison of CAS scores before and after treatment in each arm and an inter-arm
次要结局
- Quality of life questionnaires (GO-QoL)(At 0, 6 and 12 months)
- adverse events(At 0, 6 and 12 months)