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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1
The caloric intake reduction arm will been seen by the kidney disease dietitian at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3).
The University of Michigan
Ann Arbor, Michigan, United States
Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm
Time frame: Post-Perfusion (Time 0 or Study Enrollment) and 3 months
Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually.
Time frame: 3 months
Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm
3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually.
Time frame: 3 months
Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm
3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually.
Time frame: 3 months
Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio
Time frame: 3 months
Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm
Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to nephrin mRNA ratio
Time frame: 3 months
Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm
Differences in glomerular filtration rate (GFR) using both creatinine (modified diet in renal disease) as well as serum cystatin C based equations
Time frame: 3 months, 12 months
Difference in Proteinuria Between the Intervention and the Control Arm
Proteinuria measured by laboratory samples
Time frame: Measured through study completion, about 3 months
Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms
Measure the difference in HbA1c between the two arms during 3 month protocol biopsies
Time frame: 3 months
Difference in Weight of Participants in the Intervention and Control Arms
Weight as measured by pounds
Time frame: 3 months
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