Alnasrallah Basil, Pilmore Helen, Manley Paul
Department of Nephrology, Auckland City Hospital, Auckland, New Zealand.
Department of Medicine, University of Auckland, Auckland, New Zealand.
BMJ Open. 2017 Aug 23;7(8):e016813. doi: 10.1136/bmjopen-2017-016813.
Post-transplant diabetes mellitus (PTDM) is a common complication of kidney transplantation and is associated with significant morbidity and mortality. In the general population, metformin has been used for diabetes prevention in high-risk individuals. Improving insulin sensitivity is one of many proven favourable effects of metformin. Despite the high incidence of PTDM in kidney transplant recipients, there is a lack of evidence for the role of metformin in the prevention of diabetes in this setting. METHODS AND ANALYSIS: plantation and etes (Transdiab is a single-centre, unblinded, pilot randomised controlled trial assessing the feasibility, tolerability and efficacy of metformin after renal transplantation in patients with impaired glucose tolerance (IGT). Participants will undergo an oral glucose tolerance test in the 4-12 weeks post-transplantation; those with IGT will be randomised to standard care or standard care and metformin 500 mg twice daily, and followed up for 12 months. The primary outcomes of the study will be the feasibility of recruitment, the tolerability of metformin assessed using the Gastrointestinal Symptom Rating Scale at 3 and 12 months, and the efficacy of metformin assessed by morning glucose and glycated haemoglobin at 3, 6, 9 and 12 months.
Despite the significant morbidity and mortality of PTDM, there are currently no randomised clinical trials assessing pharmacological interventions for its prevention after kidney transplantation. The Transdiab trial will thus provide important data on the feasibility, safety, tolerability and efficacy of metformin after renal transplantation in patients with IGT; this will facilitate undertaking larger multicentre trials of interventions to reduce the incidence or severity of diabetes after kidney transplantation. This study has been approved by the Northern B Health and Disability Ethics Committee of the Ministry of Health in New Zealand. On study completion, results are expected to be published in a peer-reviewed journal.
Australian New Zealand Clinical Trials Registry Number: ACTRN12614001171606.
移植后糖尿病（PTDM）是肾移植常见的并发症，与显著的发病率和死亡率相关。在普通人群中，二甲双胍已被用于高危个体的糖尿病预防。改善胰岛素敏感性是二甲双胍诸多已被证实的有益作用之一。尽管肾移植受者中PTDM发病率很高，但缺乏证据表明二甲双胍在这种情况下预防糖尿病的作用。
“移植与糖尿病（Transdiab）”是一项单中心、非盲、先导随机对照试验，评估二甲双胍对糖耐量受损（IGT）的肾移植患者肾移植后预防糖尿病的可行性、耐受性和疗效。参与者将在移植后4 - 12周接受口服葡萄糖耐量试验；IGT患者将被随机分为接受标准护理或标准护理加二甲双胍500毫克每日两次，并随访12个月。该研究的主要结局将是招募的可行性、使用胃肠道症状评分量表在3个月和12个月时评估的二甲双胍耐受性，以及在3个月、6个月、9个月和12个月时通过空腹血糖和糖化血红蛋白评估的二甲双胍疗效。
尽管PTDM有显著的发病率和死亡率，但目前尚无评估肾移植后预防PTDM药物干预的随机临床试验。“移植与糖尿病（Transdiab）”试验将因此提供关于二甲双胍对IGT肾移植患者肾移植后的可行性、安全性、耐受性和疗效的重要数据；这将有助于开展更大规模的多中心干预试验，以降低肾移植后糖尿病的发病率或严重程度。本研究已获得新西兰卫生部北B健康与残疾伦理委员会的批准。研究完成后，结果预计将发表在同行评审期刊上。
澳大利亚新西兰临床试验注册编号：ACTRN12614001171606
