Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

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 Overview

• Status: Terminated
• Conditions: Weight Gain; Glomerular Disease; Kidney Transplant; Complications; Kidney Transplant
• Intervention / Treatment: Behavioral: caloric intake reduction

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: caloric intake reduction; 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).
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	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.	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.	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	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months, 12 months
Difference in Proteinuria Between the Intervention and the Control Arm	Proteinuria measured by laboratory samples	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	3 months
Difference in Weight of Participants in the Intervention and Control Arms	Weight as measured by pounds	3 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Abhijit Naik, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2019
• Primary Completion (ACTUAL): August 16, 2021
• Study Completion (ACTUAL): August 16, 2021

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Caloric Intake Reduction; Dietician
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: HUM00134686; P30DK089503 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No