Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
详细描述
Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK.
Retrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone .
These findings shed light on possible therapeutic potential of metformin in treatment of OA.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have symptomatic and radiological evidence of OA in one or both knee joints.
- •Age ≥ 45 years.
- •Both obese male and female will be included (BMI ≥ 30 kg/m²).
排除标准
- •Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.
- •Patient with hypertension or diabetes mellitus.
- •Patient with hepatic or renal impairment.
- •Patients who have active peptic ulcer.
- •Patients with positive malignancy.
- •Steroid injection into the affected knee joint within 3 months of recruitment for the study.
- •Pregnant or lactating female patients.
研究组 & 干预措施
Placebo group
Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
干预措施: Placebo Tablet (Drug)
Metformin group
Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
干预措施: Metformin Hcl 500Mg Tab (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: 12 weeks
Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.
Weight (Kg)
时间窗: 12 weeks
Measure change in weight in kilograms at baseline and after 12weeks of treatment.
次要结局
- Cartilage Oligomeric Matrix Protein (COMP)(12 weeks)
- C-terminal crosslinked telopeptide of type I collagen (CTX-1)(12 weeks)
- Interleukin 1-beta (IL-1β)(12 weeks)
- Adverse drug events(12 weeks)
研究者
Amany Abd Elaal Mohamed Aiad
pharmacist
Tanta University