Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Energy expenditure
研究概览
简要总结
Weight gain is a common complication after transplantation. It has adverse effects such as hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved by a suitable dietary intervention in these patients transplanted kidney can correct lipid disorders and facilitate balance blood pressure. The identification of mechanisms responsible for weight gain would suggest prevention strategies and allow to align the caloric energy needs of renal transplant patients.
详细描述
Weight gain is a common complication after transplantation. It has adverse effects such as hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved by a suitable dietary intervention in these patients transplanted kidney can correct lipid disorders and facilitate balance blood pressure. The identification of mechanisms responsible for weight gain would suggest prevention strategies and allow to align the caloric energy needs of renal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patient, affiliated to a social security system
- •Aged 35 to 65 years
- •Renal transplant for more than a year and less than 6 years
- •Treated by anticalcineurin
- •Patient stopped all treatment with corticosteroids for more than 3 months
- •Patient with stable renal function defined by a calculated creatinine clearance between 30 and 90 mL/min/1, 73m according to the Cockcroft and Gault
- •Written informed consent after detailed explanation of the protocol.
- •Increase in body weight of at least 3kg during the two years prior to the inclusion of 10 patients. Stable or increasing weight less than 1kg for 10 other patients.
- •HIV and HCV serology negative
排除标准
- •Female patients
- •Diabetic (type 1 or type 2) before transplantation or patients who developed diabetes after transplantation and requiring anti-diabetic treatment at the time of inclusion
- •Obese patient at the time of transplantation, as defined by a body mass index> 30%
- •Multiple kidney transplant or other organ transplant the kidney
- •Patient with lower limb edema, congestive heart failure, and/or uncontrolled hypertension.
- •Patient with a change in body weight> 3 kg in the last 3 months
- •Patient with an infection 3 months before inclusion
- •Subjects infected with hepatitis B, hepatitis C virus or human immunodeficiency
- •Patient with acute rejection within 3 months prior to inclusion
- •Patient not treated by anticalcineurin
- •Patient with a modification of immunosuppressive therapy within 3 months prior to inclusion
- •Patient with unstable psychiatric condition
- •Patient smoking> 5 cigarettes / day
- •Alcoholic patient (unweaned)
- •Patient with stage 4 renal failure (<30 mL/min/1, 73m ²) and stage 5 (<15 mL/min/1, 73m ²)
- •hemodialysis patient
- •Patient with acute renal failure defined by a 25% increase in creatinine within 3 months prior to inclusion
- •Person under guardianship or not subject to social security
- •Person in period Exclusion File National Healthy Volunteers
- •Person who refuses to give his written consent to participation
结局指标
主要结局
Energy expenditure
时间窗: at day 1
次要结局
- Food intake(at day 1)
- Insulin resistance(at day 1)
- Body composition(at day 1)
- Estimation of physical activity(at day 1)