Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover
研究概览
简要总结
An abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin cluster in these individuals. When this occurs the condition is called the 'metabolic syndrome'.
Increased activity of the sympathetic nervous system resulting in enhanced release of the stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be one factor contributing to increased noradrenaline release.
The aim of this Study is to determine whether treatment with a drug called pioglitazone which is known to improve insulin action, results in reduced sympathetic nervous system activity and stress hormone release when compared to treatment with a dummy drug (placebo).
详细描述
The rapidly growing burden of obesity together with a population that is becoming older raises the importance of effective strategies for the primary prevention and treatment of the metabolic syndrome in order to combat the epidemic of type 2 diabetes and to reduce the increased risk of cardiovascular mortality.
Increased sympathetic nervous system activity may participate in the pathogenesis and complications of the metabolic syndrome. This Study will use a randomised controlled design to evaluate the effects of pioglitazone treatment on sympathetic activity in middle-aged subjects with the metabolic syndrome.The results will generate new information on the neuroadrenergic effects of thiazolidinediones in this clinical setting. This is relevant to the understanding of the pathophysiology of the metabolic syndrome and to its clinical management.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 45-65 years,
- •non-smokers,
- •HOMA index > 2.5 and
- •who meet ATP III criteria for the metabolic syndrome
排除标准
- •History of diabetes,
- •previous MI, stroke, heart failure, impaired hepatic or renal function.
- •Inability to cease medications which may affect study parameters.
研究组 & 干预措施
Pioglitazone
pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks
干预措施: Pioglitazone (Drug)
sugar pill
Placebo comparator
干预措施: sugar pill (Drug)
结局指标
主要结局
Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover
时间窗: 12 weeks treatment
次要结局
- Baroreflex function, adrenoceptor expression(12 weeks treatment)
研究者
Nora E. Straznicky
Dr
Baker Heart Research Institute