Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

Not Applicable

Terminated

Conditions: Kidney Transplant; Complications
Glomerular Disease
Kidney Transplant
Weight Gain

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patients on dual anti platelet agents or are on oral anti coagulation medication
Patients who have had Bariatric Surgery

Arm && Interventions

Group	Intervention	Description
Caloric Intake Reduction	caloric intake reduction	The intervention group will be seen by the kidney disease dietician at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3). During months 2 and 3, in the weeks that the patients are not in clinic, they will receive telephone calls from the dietician. Thus the intervention involves weekly assessment for the first 3 months (in person or over the telephone). After 3 months, the patient will not receive any further active dietary intervention from the dieticians unless the patient wishes to continue using the dieticians advice per clinic protocol.

Primary Outcome Measures

Name	Time	Method
Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm	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	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	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms	3 months	Measure the difference in HbA1c between the two arms during 3 month protocol biopsies
Difference in Weight of Participants in the Intervention and Control Arms	3 months	Weight as measured by pounds
Difference in Proteinuria Between the Intervention and the Control Arm	Measured through study completion, about 3 months	Proteinuria measured by laboratory samples
Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm	3 months, 12 months	Differences in glomerular filtration rate (GFR) using both creatinine (modified diet in renal disease) as well as serum cystatin C based equations

Locations (1): The University of Michigan
🇺🇸
Ann Arbor, Michigan, United States