Melatonin Supplementation and the Metabolic Syndrome

描述（由申请人提供）：代谢综合征是一系列相互关联的代谢起源的危险因素，似乎可以促进动脉粥样硬化性心血管疾病的发展，增加2型糖尿病的风险。虽然存在针对某些代谢综合征成分的强有力的药物治疗，但这些治疗并不完全有效，而且往往伴有严重的副作用。因此，有相当大的兴趣寻找替代治疗代谢综合征的组成部分。这项研究计划的长远目标是寻找代谢综合征的补充和替代治疗方法。动物研究和人类观察数据表明，补充褪黑素可以预防许多代谢综合征，包括血糖升高、血压升高、血脂异常和肥胖。有证据还表明，具有代谢综合征成分的个体褪黑激素水平受到抑制，因此可能特别有可能从外源性褪黑激素补充中受益。然而，关于补充褪黑激素改善代谢综合征成分的能力的实验数据缺乏。因此，我们建议开展一项随机、双盲、安慰剂对照的交叉试验，以获得补充褪黑激素对代谢综合征成年男性和女性代谢综合征成分影响的初步数据。我们假设补充褪黑激素可以安全地缓解这些受试者的一种或多种代谢综合征成分。研究将招募36名代谢综合征患者，通过以下具体目的来验证这一假设：

DESCRIPTION (provided by applicant): The metabolic syndrome is a constellation of interrelated risk factors of metabolic origin that appear to promote the development of atherosclerotic cardiovascular disease and increase risk for type 2 diabetes. Although powerful pharmacological treatments for some metabolic syndrome components exist, these treatments are not entirely effective and are often associated with serious side-effects. Therefore, there is considerable interest in finding alternative treatments for the metabolic syndrome components. The broad, long-term objectives of this research program are to find complementary and alternative treatments for the metabolic syndrome. Animal studies and observational data in humans suggest that supplemental melatonin may provide protection against a number of metabolic syndrome components, including elevated glucose, elevated blood pressure, dyslipidemia, and obesity. Evidence also suggests that individuals with metabolic syndrome components have suppressed melatonin levels, and hence may be particularly likely to benefit from exogenous melatonin supplementation. However, experimental data on the ability of melatonin supplementation to improve metabolic syndrome components are lacking. Accordingly, we propose to conduct a pilot randomized, double-blind, placebo-controlled crossover trial that will obtain preliminary data about the effects of melatonin supplementation on metabolic syndrome components in adult men and women with the metabolic syndrome. We hypothesize that melatonin supplementation will safely alleviate one or more of the metabolic syndrome components in these subjects. Thirty-six metabolic syndrome patients will be recruited into the study to address this hypothesis through the following specific aims: 1) To obtain preliminary data on the effect of melatonin on metabolic syndrome components in persons with metabolic syndrome. 2) To explore whether sleep, oxidative stress, and inflammation are potential mechanisms that mediate the effects of melatonin on metabolic syndrome. 3) To determine whether melatonin supplementation has any adverse side-effects when taken daily for 13 weeks in adults with the metabolic syndrome. 4) To determine the feasibility of recruiting and retaining a sufficient number of metabolic syndrome patients for a larger, more definitive study. Result obtained from the study will provide necessary information for a larger, more definitive study. PUBLIC HEALTH RELEVANCE: This project is relevant to public health because it will provide much needed data on the ability of melatonin supplements to ameliorate the metabolic syndrome, which is a major risk factor for cardiovascular disease and diabetes. This study will also provide much needed information on the safety of long-term melatonin use in metabolic syndrome patients.