Exercise and Prediabetes After Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise
研究概览
简要总结
The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043).
Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).
Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.
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
- 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
- •≥ 18 years
- •≥ 12 months post kidney transplant
- •Stable renal function in the last 3-6 months
- •Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
- •Ability to perform exercise
排除标准
- •Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
- •Inability to understand the protocol
- •Severe psychological illness
- •PTDM and/or DM prior to transplantation
- •Morbid obesity
研究组 & 干预措施
Exercise group
The experimental group will receive an ad hoc designed stepped exercise intervention supported by adherence monitoring.
干预措施: Therapeutic exercise (Other)
Control group
The control group will follow standard lifestyle recommendations according to clinical practice.
结局指标
主要结局
Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise
时间窗: Baseline and every 3 months (up to 12 months)
There is an exercise programme to test the impact of this treatment on the reversibility of prediabetes. Thus, the persistance of recurrency of prediabetes assessed by an oral glucose tolerance test (OGTT) at intermediate time points (0, 3, 6, 9 and 12 months) will be checked in order to increase the intensity and duration of exercise training.
次要结局
- Compliance(Baseline and every 1.5 months (up to 12 months))
- Analytics(Baseline and every 3 months (up to 12 months))
- Anthropometric measures(Baseline and every 3 months (up to 12 months))
研究者
Raúl Morales Febles
PhD-Physiotherapist
University of La Laguna