Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostate on Gouty Obese Non-Diabetic Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in serum uric acid level
研究概览
简要总结
Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (>6.8 mg/dl) is a requirement for the formation of uric acid crystals. MSU crystals can be deposited in all tissues mainly in and around the joints forming tophi. Early presentation of gout is an acute joint inflammation that is quickly relieved by non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Lowering SUA levels below deposition threshold either by dietary modification or using serum uric acid lowering drugs is the main goal in management of gout. This results in dissolution of MSU crystals preventing further attacks
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)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged < 18 years.
- •All patients are diagnosed to have gout with serum uric acid < 7 mg/dl.
- •All patients are diagnosed to have obesity with body mass index (BMI) ≥ 30 kg/m2.
排除标准
- •The presence of any type of diabetes mellitus.
- •Patients with drug-induced hyperuriceamia (those taking anti-TB agents, low dose aspirin, cytotoxic chemotherapy, diuretics, immunosuppressants, fructose, lactate infusion, testosterone or xylitol).
- •Non-obese patients with BMI >30 kg/m
- •Pregnant or lactating women.
研究组 & 干预措施
Control group
patients will receive febuxostat 80 mg daily for 6 months.
干预措施: Febuxostat Tablets (Drug)
Metformin group
patients will receive metformin 1000 mg daily for 6 months
干预措施: Febuxostat Tablets (Drug)
Metformin group
patients will receive metformin 1000 mg daily for 6 months
干预措施: Metformin (Drug)
结局指标
主要结局
Change in serum uric acid level
时间窗: 3 months
Serum uric acid is the major metabolite of purine pathway and used in diagnosis of gouty patients
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Lecturer
Tanta University