Htike Z Z, Yates T, Brady E M, Webb D, Gray L J, Swarbrick D, McCann G P, Khunti K, Davies M J
NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, Leicester Diabetes Centre, Leicester General Hospital, Leicester, UK and Health Sciences, University of Leicester, Leicester, UK.
Department of Cardiovascular Sciences, Glenfield Hospital, University of Leicester, Leicester, UK.
Cardiovasc Diabetol. 2016 Jul 21;15(1):102. doi: 10.1186/s12933-016-0421-6.
The prevalence of type 2 diabetes (T2DM) in younger adults is growing. Compared to the late onset T2DM, it is well recognized that the disease tends to behave more aggressively in the younger age group with evidence of premature micro and macrovasular diseases and shorter life span. This increased mortality is largely attributed to cardiovascular complications. In a recent pilot study, young adults with T2DM were found to have significantly lower peak diastolic strain rate (PEDSR) on cardiac MRI (CMR), a forerunner of diabetic cardiomyopathy. Liraglutide, a glucagon like peptide-1 (GLP-1) analogue, is one of the new classes of glucose lowering therapies licensed to be used in management of T2DM. In randomised controlled trials, liraglutide improves glycaemic control by 1-1.5 % with an added benefit of weight loss of 2-3 kg. In addition, there is emerging evidence elucidating the cardioprotective effects of GLP-1 analogues independent of glycaemic control. In a small study, liraglutide has also been shown to improve cardiac function in patients with coronary ischaemia or congestive heart failure.
This is a prospective, randomised, open-label, blind end-point (PROBE) active-comparator trial. A total of 90 obese eligible participants with T2DM (18-50 years) will be randomised to either liraglutide 1.8 mg once daily or sitagliptin 100 mg once daily for 26 weeks. The primary aim is to assess whether liraglutide improves diastolic function compared to sitagliptin as measured by PEDSR using CMR.
Although newer classes of GLP-1 analogues are made available in recent years, there are very few published studies demonstrating the beneficial effect of GLP-1 analogues on cardiovascular endpoints. In a recently published LEADER study, liraglutide has shown superiority to placebo in a population of type 2 diabetes with high risk of cardiovascular disease. To the best of our knowledge, there are no published studies establishing the effect of liraglutide on cardiac function in younger patients with T2DM on a larger scale. The LYDIA study will comprehensively describe changes in various parameters of cardiac structure and function in patients treated with liraglutide aiming to provide new evidence on effect of liraglutide on diastolic function in young obese people with T2DM. Trial Registration ClinicalTrials.gov identifier: NCT02043054.
2型糖尿病（T2DM）在年轻成年人中的患病率正在上升。与晚发型T2DM相比，人们普遍认识到该疾病在较年轻年龄组中往往表现得更具侵袭性，有微血管和大血管疾病过早出现以及寿命缩短的证据。这种死亡率的增加很大程度上归因于心血管并发症。在最近一项试点研究中，发现患有T2DM的年轻成年人在心脏磁共振成像（CMR）上的舒张末期峰值应变率（PEDSR）显著降低，这是糖尿病性心肌病的先兆。利拉鲁肽是一种胰高血糖素样肽-1（GLP-1）类似物，是被许可用于T2DM管理的新型降糖疗法之一。在随机对照试验中，利拉鲁肽可使血糖控制改善1%-1.5%，并额外带来2-3千克的体重减轻。此外，越来越多的证据表明GLP-1类似物具有独立于血糖控制的心脏保护作用。在一项小型研究中，利拉鲁肽还被证明可改善冠心病或充血性心力衰竭患者的心脏功能。
这是一项前瞻性、随机、开放标签、盲终点（PROBE）活性对照试验。总共90名符合条件的肥胖T2DM参与者（18-50岁）将被随机分为每日一次注射1.8毫克利拉鲁肽组或每日一次口服10毫克西他列汀组，为期26周。主要目的是评估与西他列汀相比，利拉鲁肽是否能通过CMR测量的PEDSR改善舒张功能。
尽管近年来有新型的GLP-1类似物可供使用，但很少有已发表的研究证明GLP-1类似物对心血管终点的有益作用。在最近发表的LEADER研究中，利拉鲁肽在心血管疾病高风险的2型糖尿病患者群体中显示出优于安慰剂的效果。据我们所知，尚无已发表的大规模研究确定利拉鲁肽对年轻T2DM患者心脏功能的影响。LYDIA研究将全面描述接受利拉鲁肽治疗的患者心脏结构和功能的各种参数变化，旨在为利拉鲁肽对年轻肥胖T2DM患者舒张功能的影响提供新证据。试验注册ClinicalTrials.gov标识符：NCT02043054。
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