The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in serum levels of neurofilament light chain in both arms
研究概览
简要总结
This pilot study aims to investigate the tolerability and feasibility of using metformin as an adjuvant treatment for RRMS. Also, it aims to evaluate the preliminary evidence of its efficacy by analyzing outcomes related to immunology, clinical manifestations, and radiological findings.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between 18 and 50 years of age who met the 2017 McDonald criteria were recruited.
- •Patients with RRMS and had an EDSS score below 7.
- •Participants were required to have been on a stable IFNβ-1a regimen for at least six months before the commencement of the study.
排除标准
- •Individuals taking metformin or other diabetes medications, pregnant, and breastfeeding females were excluded.
- •Those with congestive heart failure, liver impairment, kidney dysfunction, or chronic respiratory conditions were not eligible to participate.
- •Additionally, patients who had undergone corticosteroids before or within 4 weeks of the study's commencement were ineligible for participation.
研究组 & 干预措施
Control group
Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
干预措施: Usual Care (Other)
Intervention group
Experimental: Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®) Metformin 1000 mg (Cidophage® 1000 mg tablets, CID, Giza, Egypt) tablet twice daily for 6 months as add on therapy with Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®).
干预措施: Metformin (Cidophage®) (Drug)
结局指标
主要结局
Change in serum levels of neurofilament light chain in both arms
时间窗: After 6 months
次要结局
- Change in serum levels of nuclear factor kappa B in both arms(After 6 months)
- Degree of remyelination visualized by MRI, it depends on clinician's overview.(After 6 months)
- Degree of disability assessed by Expanded Disability Status Scale.(After 6 months)
研究者
Mohamed Youssef Elsayed
The Effect of Metformin as an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: A Pilot Study
German University in Cairo