Melatonin Supplementation and the Metabolic Syndrome

褪黑激素补充剂和代谢综合症

• 批准号: 8309850
• 负责人: Michael Henry Kutner
• 金额: $ 7.75万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8309850
• 关键词: Address; Adult; Adverse effects; Animals; Atherosclerosis; Blood Pressure; Cardiovascular Diseases; Cross-Over Studies; Data; Development; Diabetes Mellitus; Double-Blind Method; Dyslipidemias; Glucose; Human; Individual; Inflammation; Malignant Neoplasms; Mediating; Melatonin; Metabolic; Metabolic syndrome; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Observational Study; Oxidative Stress; Patients; Persons; Pharmacological Treatment; Placebo Control; Public Health; Randomized; Recruitment Activity; Research; Risk; Risk Factors; Safety; Sleep; Supplementation; Woman; alternative treatment; design; improved; interest; men; programs; public health relevance

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.

描述（由申请人提供）：代谢综合征是一系列代谢来源的相关风险因素，这些因素似乎促进动脉粥样硬化性心血管疾病的发展并增加2型糖尿病的风险。虽然存在针对某些代谢综合征组分的强大药物治疗，但这些治疗并不完全有效，并且通常与严重的副作用相关。因此，有相当大的兴趣在寻找替代治疗代谢综合征的组成部分。这项研究计划的广泛，长期目标是寻找代谢综合征的补充和替代治疗。动物研究和人类观察数据表明，补充褪黑激素可以提供对许多代谢综合征组分的保护，包括血糖升高、血压升高、血脂异常和肥胖。证据还表明，代谢综合征的组成部分的个人有抑制褪黑激素水平，因此可能特别有可能受益于外源性褪黑激素补充剂。然而，缺乏关于补充褪黑激素改善代谢综合征组分的能力的实验数据。因此，我们建议进行一项随机、双盲、安慰剂对照的交叉试验，以获得关于补充褪黑激素对代谢综合征成年男性和女性代谢综合征组分影响的初步数据。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。本研究将招募36名代谢综合征患者，以通过以下特定目的来解决这一假设： 1)获得褪黑激素对代谢综合征患者代谢综合征组分影响的初步数据。 2)探讨睡眠、氧化应激和炎症是否是介导褪黑素对代谢综合征作用的潜在机制。 3)为了确定褪黑激素补充剂是否有任何不良副作用时，每天服用13周的成人代谢综合征。 4)确定招募和保留足够数量的代谢综合征患者进行更大规模、更明确研究的可行性。从研究中获得的结果将为更大，更明确的研究提供必要的信息。 公共卫生相关性：该项目与公共卫生有关，因为它将提供急需的数据，说明褪黑激素补充剂改善代谢综合征的能力，代谢综合征是心血管疾病和糖尿病的主要危险因素。这项研究还将提供代谢综合征患者长期使用褪黑激素的安全性方面急需的信息。

项目成果

Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.

• DOI: 10.1186/1758-5996-6-124
• 发表时间: 2014
• 期刊: Diabetology & metabolic syndrome
• 影响因子: 4.8
• 作者: Goyal A;Terry PD;Superak HM;Nell-Dybdahl CL;Chowdhury R;Phillips LS;Kutner MH
• 通讯作者: Kutner MH