Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Insulin resistance (HOMA index)
研究概览
简要总结
Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.
详细描述
60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, age 40 -65 yrs
排除标准
- 未提供
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
Allopurinol given for 2 weeks with diet
干预措施: Allopurinol (Drug)
结局指标
主要结局
Insulin resistance (HOMA index)
时间窗: 2 weeks
Blood pressure
时间窗: 2 weeks
Triglycerides, HDL cholesterol
时间窗: 2 weeks
次要结局
- Adiponectin(2 weeks)
- Leptin(2 weeks)
- CRP level(2 weeks)
- Weight gain(2 weeks)