Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
研究概览
简要总结
One possible reason that weight gain after transplant may interfere with new kidney function is due to the enlargement of a kidney structure called the glomerulus.
The researchers believe that modest caloric intake reduction (CIR) early after kidney transplantation can reduce the enlargement (hypertrophy) of the glomerulus associated with kidney transplantation and may improve long term allograft survival, by reducing glomerular hypertrophy mediated progressive glomerulosclerosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of kidney transplants where a post perfusion biopsy is obtained
- •Body Mass Index between 25-30 kg/m2 at the time of randomization
- •Non-diabetic
- •Have a smart phone or active internet connection at home
排除标准
- •Patients on dual anti platelet agents or are on oral anti coagulation medication
- •Patients who have had Bariatric Surgery
结局指标
主要结局
Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
时间窗: 3 months
3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually.
Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm
时间窗: Post-Perfusion (Time 0 or Study Enrollment) and 3 months
Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm
时间窗: 3 months
3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually.
Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm
时间窗: 3 months
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to nephrin mRNA ratio
Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm
时间窗: 3 months
3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually.
Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm
时间窗: 3 months
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio
次要结局
- Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms(3 months)
- Difference in Weight of Participants in the Intervention and Control Arms(3 months)
- Difference in Proteinuria Between the Intervention and the Control Arm(Measured through study completion, about 3 months)
- Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm(3 months, 12 months)
研究者
Abhijit Naik
Associate Professor of Internal Medicine
University of Michigan