PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study
PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study
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DOI：
10.1186/s13063-019-3392-6
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发表时间：
2019-06-21
期刊：
影响因子：
2.5
通讯作者：
Ducloux, D.
中科院分区：
文献类型：
--
作者：
Gaiffe, E.;Crepin, T.;Ducloux, D.
背景肾移植术后糖尿病是肾移植术后常见而严重的并发症。目前还没有预防或延缓这种疾病的治疗方法。然而，风险因素的识别使得有可能针对有新发糖尿病风险的人群。我们假设，短期治疗与vildagelide可以防止新发糖尿病移植后（NODAT）在高危patients.Methods/design这是一个多中心，双盲，安慰剂对照的随机临床试验。接受首次肾移植的患者将来自10个法国移植中心。入选的患者将随机（1：1）接受100或50 mg/天（取决于肾小球滤过率）或安慰剂治疗，持续2个月（首次给药在进入手术室前）。可根据血糖控制情况给予额外的降糖治疗。主要结果是移植后1年糖尿病患者的比例，定义为接受糖尿病治疗或空腹血糖高于7 mmol/l和/或口服葡萄糖耐量试验异常的患者。次要结果包括糖化血红蛋白，急性排斥反应的发生，感染，移植物丢失和移植后3个月，6个月和12个月的患者死亡。结果将与患者的临床和一般特征，心血管病史，肾病，透析史，移植数据，生物学数据，健康相关的生活质量，以及预防糖尿病的成本效益与vildagelid.DiscussionWe有稀缺的数据移植后糖尿病的药理学预防。如果我们的假设得到验证，我们的研究结果将直接应用于临床实践，并可能限制糖尿病相关的发病率，减少心血管并发症，提高肾移植患者的生活质量，从而提高移植物和患者的生存率。我们的结果可能适用于患有与其他合并症相关的糖尿病高风险的非移植患者。试验registrationClinicalTrials.gov，NCT 02849899。于2016年2月8日注册。
BackgroundPost-transplant diabetes is a frequent and serious complication of kidney transplantation. There is currently no treatment to prevent or delay the disease. Nevertheless, identification of risk factors make it possible to target a population at risk of developing de novo diabetes. We hypothesized that a short-term treatment with vildagliptin may prevent new onset diabetes after transplantation (NODAT) in high-risk patients.Methods/designThis is a multicenter, double-blind, placebo-controlled randomized clinical trial. Patients undergoing first kidney transplantation will be included from ten French transplant centers. Included patients will be randomized (1:1) to receive either vildagliptin 100 or 50mg/day (depending on glomerular filtration rate) during 2months (the first dose being administered before entering the operating theatres) or placebo. Additional antidiabetic therapy could be administered according to glycemic control. The primary outcome is the proportion of diabetic patients 1year after transplantation, defined as patients receiving a diabetic treatment, or having a fasting glucose above 7mmol/l, and/or with an abnormal oral glucose tolerance test. Secondary outcomes include glycated hemoglobin, the occurrence of acute rejection, infection, graft loss and patient death at 3months, 6months, and 12months after transplantation. Outcomes will be correlated to clinical and general characteristics of the patient, cardiovascular history, nephropathy, dialysis history, transplantation data, biological data, health-related quality of life, and the cost-effectiveness of prevention of diabetes with vildagliptin.DiscussionWe have scarce data on the pharmacological prevention of post-transplant diabetes. If our hypothesis is verified, our results will have a direct application in clinical practice and could limit diabetes-associated morbidity, reduce cardiovascular complications, increase quality of life of renal transplant patients, and consequently promote graft and patient survival. Our results may possibly serve for non-transplant patients carrying a high-risk of diabetes associated with other co-morbidities.Trial registrationClinicalTrials.gov, NCT02849899. Registered on 8 February 2016.