Multicenter, Randomized, Controlled Clinical Trial Research Evaluating the Use of Combination Therapy of Glucocorticoids and Metformin to Decrease Glucocorticoids Side Effects in Patients With Autoimmune Uveitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The incidence of abnormal metabolic indexes
研究概览
简要总结
This project is designed to evaluating the use of combination therapy of glucocorticoid and metformin to decrease glucocorticoid side effects in participants with autoimmune uveitis.This study also aims to evaluate the anti-inflammatory and immunosuppressive effects of combination therapy.
详细描述
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All participants were provided with written informed consent and received a thorough explanation of the study design, aims, and the side effect of metformin. This is a multicenter, randomized, controlled clinical trial research. According to 1:1 ratio, all participants are randomly divided into two groups, the metformin group and placebo group.
According to the fasting blood glucose (FBG), triglycerides (TG),total cholesterol (TC) and body mass index (BMI), the investigators compared experimental group with control group to evaluate whether the use of combination therapy of glucocorticoid and metformin decrease glucocorticoid side effects in participants with autoimmune uveitis.
According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, fluorescence fundus angiography (FFA), electroretinogram (ERG) and so on, the investigators evaluate the anti-inflammatory and immunosuppressive effects of metformin in treatment of autoimmune uveitis.
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
- Double (Participant, Investigator)
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
- •Attending Tianjin Medical University Eye Hospital, ophthalmology department of Peking Union Medical College Hospital, ophthalmology department of Peking University First Hospital and Zhongshan Ophthalmic Center Sun Yat-sen University from January 2018 to January
- •Chronic and non-infectious autoimmune uveitis with systemic glucocorticoids treatment (Initiation dosage ≥ 1 mg/kg/d or ≥ 50 mg/d).
- •FBG < 6.1 mmol/L, HbAlc<6.O%, TC <6.2 mmol/L(240 mg／d1) and TG <2.3 mmol/L(200 mg／dl).
- •All genders, age ≥ 18 years old.
- •Ready for systemic glucocorticoids treatment.
- •Willing to follow all study requirements and sign the informed consent.
- •Without history of cancer and serious systemic diseases.
排除标准
- •Participate in other clinical trials within the preceding one years
- •Planning ophthalmologic surgery over the next three months.
- •With other sight-threatening diseases except cataract, such as glaucoma, diabetic retinopathy, retinal detachment, and so on.
- •Taking or will take immunosuppressants which affecting glycometabolism and lipid metabolism except methotrexate,mycophenolate and azathioprine.
- •Any known history of a serious infection (e.g., HIV, hepatitis, pneumonia, syphilis or tuberculosis).
- •Any known history of diabetes mellitus, severe hepatic, renal or heart disease.
- •Any known history of drug addiction, drug abuse and malignant tumor.
- •Presence of a transplanted solid organ.
- •Pregnant women and nursing mothers.
- •Any known history of mental disorders.
研究组 & 干预措施
Placebo group
Oral placebo 500 mg once daily for first week, 500 mg twice daily for next 23 weeks. The follow-up treatment according to the participants' condition.
干预措施: Placebo (Drug)
Metformin group
Oral metformin 500 mg once daily for first week, 500 mg twice daily for next 23 weeks. The follow-up treatment according to the participants' condition.
干预措施: Metformin (Drug)
结局指标
主要结局
The incidence of abnormal metabolic indexes
时间窗: 24 weeks
The assessments of abnormal metabolic indexes include any of these outcome measures: FBG≥6.1 mmol/L, TC≥6.2 mmol/L (240 mg/d1), TG≥2.3 mmol/L (200 mg/dl) or BMI increased 1 kg/m\^2 than before in the process of follow-up twice in a row.
次要结局
未报告次要终点
研究者
Xiaomin Zhang
Director of the Tianjin Medical University Eye Institute，archiater
Tianjin Medical University