NCT04075110已完成早期 1 期
Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
Sadat City University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent change in body weight
研究概览
简要总结
The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years.
排除标准
- •patients who had any other inflammatory disease
- •patients with cardiovascular,
- •patients with asthma
- •patients with severe hepatic
- •patients with renal disease,
- •patients with epilepsy
- •pregnant or lactating females.
研究组 & 干预措施
Control group
Placebo Comparator
50 patients will receive metformin up to 2000mg/daily (Control group)
干预措施: Placebo (Drug)
Montelukast group
Experimental
50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day).
干预措施: Montelukast 10mg (Drug)
结局指标
主要结局
Percent change in body weight
时间窗: From baseline to 12 weeks
Body Weight
Visceral Adiposity Index
时间窗: From baseline to 12 weeks
visceral fat
Change in HbA1c
时间窗: From baseline to 12 weeks
HbA1c
BMI
时间窗: From baseline to 12 weeks
body mass index
次要结局
- Adiponectin(At baseline to 12 weeks)
- TNF-α(At baseline to 12 weeks)
- IL-6(At baseline to 12 weeks)
- leukotriene B4(At baseline to 12 weeks)
研究者
Mahmoud Samy Abdallah
Lecturer of Clinical Pharmacy, PhD.
Sadat City University
研究点 (1)
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