Back to resultsEffect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
Primary Purpose
Kidney Transplant; Complications, Glomerular Disease, Weight Gain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
caloric intake reduction
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplant; Complications focused on measuring Caloric Intake Reduction, Dietician
Eligibility Criteria
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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Caloric Intake Reduction
Standard of care
Arm Description
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.
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 Outcome Measures
Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm
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.
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.
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.
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
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
Secondary Outcome Measures
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
Difference in Proteinuria Between the Intervention and the Control Arm
Proteinuria measured by laboratory samples
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
Difference in Weight of Participants in the Intervention and Control Arms
Weight as measured by pounds
Full Information
NCT ID
NCT03607500
First Posted
July 20, 2018
Last Updated
January 18, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03607500
Brief Title
Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
Official Title
Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications, Glomerular Disease, Weight Gain, Kidney Transplant
Keywords
Caloric Intake Reduction, Dietician
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caloric Intake Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
caloric intake reduction
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Title
Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
Description
3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually.
Time Frame
3 months
Title
Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm
Description
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
Title
Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm
Description
3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually.
Time Frame
3 months
Title
Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm
Description
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
Title
Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm
Description
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
Secondary Outcome Measure Information:
Title
Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm
Description
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
Title
Difference in Proteinuria Between the Intervention and the Control Arm
Description
Proteinuria measured by laboratory samples
Time Frame
Measured through study completion, about 3 months
Title
Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms
Description
Measure the difference in HbA1c between the two arms during 3 month protocol biopsies
Time Frame
3 months
Title
Difference in Weight of Participants in the Intervention and Control Arms
Description
Weight as measured by pounds
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhijit Naik, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
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