Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

NCT03607500 | Terminated Results

• 2 other identifiers: HUM00134686P30DK089503
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Caloric Intake Reduction; Dietician

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm

  3 months, 12 months

• Difference in Proteinuria Between the Intervention and the Control Arm

  Measured through study completion, about 3 months

• 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

Study Arms (2)

Caloric Intake Reduction

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

caloric intake reduction BEHAVIORAL

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).

Caloric Intake Reduction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Abhijit Naik
• Organization: University of Michigan

abhinaik@med.umich.edu

734-763-0990

Study Officials

• Abhijit Naik, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: August 22, 2019
• Primary Completion: August 16, 2021
• Study Completion: August 16, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)