PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant period
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 9
- 主要终点
- the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)
研究概览
简要总结
to demonstrate that a short term treatment of vildagliptin administered in the early post-transplant period prevents the occurrence of post-transplant diabetes one year after kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient receiving a first kidney transplant
- •Patients considered at high risk of developing posttransplant diabetes having at least 2 of the 3 following criteria: Age> 50 years; BMI greater than 30 kg/m²; Direct Family history of type 2 diabetes
- •Patients who can receive immunosuppressive therapy including tacrolimus, mycophenolic acid and steroids
- •Patients in whom the cessation of steroids may be considered at the latest at Month 3 post-transplant
排除标准
- •Hepatic insufficiency
- •Patient with Class IV NYHA Heart Failure
- •Patient with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
- •Active infection
- •Infection with Hepatitis C virus
- •Multi-Organ Transplantation
- •A history of diabetes / pancreatitis /angioedema
结局指标
主要结局
the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)
the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)
次要结局
- The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation
- The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,
- The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,
- The cost of the care and treatment up to one year after transplantation.
研究者
Pr Didier DUCLOUX
Scientific
Centre Hospitalier Regional Universitaire