欧洲高血糖人群糖尿病微血管并发症的早期预防。ePREDICE 随机试验。研究方案、招募情况和部分基线数据。
Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data.
机构信息
Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain.
World Community for Prevention of Diabetes Foundation (WCPD), Madrid, Spain.
出版信息
PLoS One. 2020 Apr 13;15(4):e0231196. doi: 10.1371/journal.pone.0231196. eCollection 2020.
OBJECTIVES
To assess the effects of early management of hyperglycaemia with antidiabetic drugs plus lifestyle intervention compared with lifestyle alone, on microvascular function in adults with pre-diabetes.
METHODS
Trial design: International, multicenter, randomised, partially double-blind, placebo-controlled, clinical trial.
PARTICIPANTS
Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey.
INTERVENTION
Participants were randomized to placebo; metformin 1.700 mg/day; linagliptin 5 mg/day or fixed-dose combination of linagliptin/metformin. All patients were enrolled in a lifestyle intervention program (diet and physical activity). Drug intervention will last 2 years. Primary Outcome: composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index. Secondary outcomes in a subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function.
RESULTS
One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin. A total of 809 people (91.1%) accepted and initiated the assigned treatment. Study sample after randomization was well balanced among the four groups. No statistical differences for the main risk factors analysed were observed between those accepting or rejecting treatment initiation. At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%.
CONCLUSIONS
ePREDICE is the first -randomized clinical trial with the aim to assess effects of different interventions (lifestyle and pharmacological) on microvascular function in people with pre-diabetes. The trial will provide novel data on lifestyle modification combined with glucose lowering drugs for the prevention of early microvascular complications and diabetes.
REGISTRATION
- ClinicalTrials.Gov Identifier: NCT03222765 - EUDRACT Registry Number: 2013-000418-39.
目的
评估与单独生活方式干预相比，用降糖药物进行早期高血糖管理对糖尿病前期成年人微血管功能的影响。
方法
试验设计：国际、多中心、随机、部分双盲、安慰剂对照、临床试验。
参与者
年龄在 45-74 岁之间的男性和女性，患有 IFG、IGT 或 IFG+IGT，从澳大利亚、奥地利、保加利亚、希腊、科威特、波兰、塞尔维亚、西班牙和土耳其的基层医疗中心招募。
干预措施
参与者被随机分配至安慰剂组；二甲双胍 1700mg/天；利拉利汀 5mg/天或利拉利汀/二甲双胍固定剂量联合治疗组。所有患者均参加生活方式干预计划（饮食和体育活动）。药物干预将持续 2 年。主要结局：通过早期糖尿病视网膜病变研究评分估计的糖尿病视网膜病变复合终点、尿白蛋白与肌酐比值以及通过汗指数估计的足部皮肤传导。亚组中的次要结局包括胰岛素敏感性、β细胞功能、炎症和脂肪肝生物标志物、生活质量、认知功能、抑郁症状和内皮功能。
结果
共有 1391 名高血糖患者接受了资格评估，424 名在筛查后被排除，967 名被分配至安慰剂、二甲双胍、利拉利汀或二甲双胍+利拉利汀固定剂量联合治疗组。共有 809 人（91.1%）接受并开始接受指定治疗。随机分组后的研究样本在四组之间平衡良好。接受或拒绝治疗开始的主要危险因素分析之间没有统计学差异。基线时糖尿病视网膜病变的患病率为 4.2%，严重神经病变为 5.3%，肾病为 5.7%。
结论
ePREDICE 是第一项旨在评估不同干预措施（生活方式和药物）对糖尿病前期人群微血管功能影响的随机临床试验。该试验将提供关于生活方式改变与降血糖药物联合预防早期微血管并发症和糖尿病的新数据。
登记
-ClinicalTrials.Gov 标识符：NCT03222765 - EUDRACT 注册号：2013-000418-39。
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