A Prospective, Randomised Controlled Trial Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Glucose metabolism
研究概览
简要总结
Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney transplantation, related to both transplant-specific and generic risk factors, and is associated with major complications after transplantation. The current PTDM Consensus Report recommends lifestyle modification (e.g. weight loss, dietary modification, structured exercise program) as the first line therapy of choice. No recommendation is given with regards to how such guidance should be delivered. In addition no clinical evidence exists to suggest lifestyle modification provides any sustained glycaemic benefits for kidney allograft recipients.
While in the general population the benefits of lifestyle modification have been well documented with regards to attenuation of both pre-diabetic and diabetic states in the context of randomised controlled trials, no similar level of evidence exists post kidney transplantation.
This prospective randomised controlled trial is designed to compare active versus passive lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic risk profile over the course of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant
排除标准
- •Organ transplant recipient, pre-existing diabetes, pregnancy
结局指标
主要结局
Glucose metabolism
时间窗: 6 months
Change in insulin secretion, insulin resistance and disposition index (insulin secretion x insulin sensitivity) between baseline and post-intervention
次要结局
- Difference in HbA1c(6 months)
- Change in lipid profile(6 months)
- Commencement of glucose-lowering therapy(6 months)
- Incidence of Impaired Glucose Tolerance(6 months)
- Physical changes (weight, body mass index, waist-hip ration and triceps fold thickness)(6 months)
- Change in blood pressure(6 months)
- Change in urine albumin-creatinine ratio(6 months)
- Incidence of Post-Transplantation Diabetes Mellitus(6 months)
- Incidence of Impaired Fasting Glucose(6 months)
- Change in physical activity(6 months)
- Change in creatinine(6 months)
- Change in psychological well-being(6 months)
- Patient survival(6 months and then 1-, 3-, 5- and 10-years post transplantation)
- Allograft survival(6 months and then 1-, 3-, 5- and 10-years post transplantation)
- Hospitalization(6 months and then 1-, 3-, 5- and 10-years post transplantation)
研究者
Adnan Sharif
Consultant Nephrologist
University Hospital Birmingham NHS Foundation Trust