Exercise, Prediabetes and Diabetes After Renal Transplantation.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Oral glucose tolerance test (OGTT)
研究概览
简要总结
This study is designed to evaluate the feasibility of exercise to reverse prediabetes after transplantation to prevent Posttransplantation Diabetes Mellitus (PTDM).
详细描述
The hypothesis of the study is that exercise will promote the reversibility to normal glucose metabolism in patients with prediabetes and eventually reduce the incidence of PTDM in renal transplant. The main objective of the study is to induce the reversibility of prediabetes by means of exercise. Additionally, the secondary objectives are: (a) to evaluate the compliance of exercise (b) improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old.
- •Renal transplantation: beyond 6-12 months after transplantation with stable renal function
- •IFG: 100-125 mg/dl and IGT 140-199 mg/dl.
- •Ability or capacity to perform exercise.
排除标准
- •Clinical conditions that preclude the treatment with exercise i.e. clinical instability: active infection, cancer, acute cardiovascular disease, advanced renal disease, pulmonar hypertension, chronic obstructive pulmonary disease, severe reumatological disorders, arthrosis, arthritis limb amputation, etc.
- •Inability to understand the protocol.
- •Severe psychological disease.
- •Diabetes before transplantation.
结局指标
主要结局
Oral glucose tolerance test (OGTT)
时间窗: Baseline and 3 months-12 months, every 3 months
After a 10-12 h overnight fast, a standard 75-g OGTT with samples taken at 0 min (glucose-insulin) and 120 minutes (glucose) will be performed at screening-baseline and after 3,6,9,12 months. Patients must be clinically stable without conditions that could induce transient hyperglycaemia or insulin resistance, i.e. infections, acute rejection, renal failure or cardiovascular disease. The presence of any of these conditions postponed the test for at least 3 months after full recovery. Also, serum and urinary samples will be taken and storage at -80 degrees.
次要结局
- Compliance(Baseline and 3 months-12 months, every 3 months)
- Anthropometric measures(Baseline and 3 months-12 months, every 3 months)
- Test the reversibility of prediabetes(Baseline and 3 months-12 months, every 3 months)
- Analitics(Baseline and 3 months-12 months, every 3 months)
- Cardiorrespiratory fitness test(Baseline and 3 months-12 months, every 3 months)