Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of hyperuricemia treatment on systemic blood pressure
研究概览
简要总结
The purpose of this study is to evaluate the influence of hyperuricemia treatment compared with placebo on participants with high risk of hypertension and metabolic syndrome.
详细描述
Elevated consumption of high fructose corn syrup has lead to an increase of 30% of fructose intake since the last 20 years. Important data supporting this fact can be reflected on incidence and prevalence of Metabolic syndrome and hyperuricemia.
A peculiar effect of fructose intake demonstrated in animal models is the development of elevated uric acid levels; also some studies have found a clear association between hyperuricemia as an important risk factor for hypertension, diabetes mellitus, chronic kidney disease and metabolic syndrome.
Taking into account the existing evidence, our clinical research team presents this protocol as a way to evaluate the effect of uric acid treatment and its relation with Fructose consumption, metabolic syndrome parameters, hyperuricemia and risk of hypertension.
Confirming evidence with clinical basis may be the initial strategy to create primary prevention programs to control this health problems affecting Mexican Population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg
- •no pharmacological treatment for blood pressure control
排除标准
- •hypertension (more than 140/90mmHg)
- •Diabetes Mellitus type 1 or 2
- •Chronic kidney disease (MDRD less than 60)
- •Hepatic Disease
- •Malignancy
- •Pregnancy
- •patient receiving any medication
研究组 & 干预措施
Allopurinol treatment
干预措施: Allopurinol (Drug)
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Effect of hyperuricemia treatment on systemic blood pressure
时间窗: 14 weeks
participants will be randomized to a 4 week placebo versus alopurinol treatment followed by a wash out period. After crossover them, they will receive the complementary pharmacological intervention for another 4 weeks.
次要结局
- Effect of hyperuricemia treatment on metabolic syndrome parameters(14 weeks)
研究者
Magdalena Madero
Chief Nephrology Division
Instituto Nacional de Cardiologia Ignacio Chavez