Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Michigan
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients on dual anti platelet agents or are on oral anti coagulation medication
- •Patients who have had Bariatric Surgery
Arms & Interventions
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.
Intervention: caloric intake reduction (Behavioral)
Standard of care
The standard of care arm will receive dietary guidance per current University of Michigan Transplant Center policy, where a one time face-to-face visit is provided in the first month after kidney transplant and then as requested by the patient or referred by physician.
Outcomes
Primary Outcomes
Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
Investigators
Abhijit Naik
Associate Professor of Internal Medicine
University of Michigan