The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serological remission criteria
研究概览
简要总结
Objective:
To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.
Methods:
A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
详细描述
Background: Metformin has anti-inflammatory properties, as it suppresses the inflammatory process by down-regulating the transcription factor, nuclear factor kappa B (NF-kB), through AMP-activated protein kinase (AMPK)-dependent and independent pathways.
Objective
To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality.
Methods:
A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyzed at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gouty patients who fulfilled the American College of Rheumatology clinical criteria.
- •gouty patients with active inflammatory arthritis.
排除标准
- •Patients with any type of inflammatory arthritis.
- •Patients with systemic disease as diabetes, hypertension,
- •Patients with hyperlipidemia, coronary artery disease,
- •Patients with renal or hepatic insults,
- •pregnant and lactating females
研究组 & 干预措施
group 1: gouty patients on metformin.
metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months.
干预措施: Metformin (Drug)
gouty patients on placebo.
placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Serological remission criteria
时间窗: at 3 months post intervention.
by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.
Articular remission criteria
时间窗: at 3 months post intervention.
by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..
Clinical remission criteria
时间窗: at 3 months post intervention.
by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale
次要结局
- Gout Impact Scale (GIS)(at 3 months post intervention.)
研究者
Dalia Salah Saif
Assistant professor of physical medicine,rheumatology and rehabilitation.
Menoufia University