Clinical trial NCT03607500: 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
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Transplant; Complications
Glomerular Disease
Weight Gain
Kidney Transplant
Keywords: Caloric Intake Reduction
Dietician
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-07-31
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Difference in the Change in Baseline and 3 Month Glomerular Volume Between the Intervention and the Control Arm
timeFrame: Post-Perfusion (Time 0 or Study Enrollment) and 3 months
measure: Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm
timeFrame: 3 months
measure: Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm
timeFrame: 3 months
measure: Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm
timeFrame: 3 months
measure: Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm
timeFrame: 3 months
measure: Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm
timeFrame: 3 months
Secondary outcomes:
measure: Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm
timeFrame: 3 months, 12 months
measure: Difference in Proteinuria Between the Intervention and the Control Arm
timeFrame: Measured through study completion, about 3 months
measure: Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms
timeFrame: 3 months
measure: Difference in Weight of Participants in the Intervention and Control Arms
timeFrame: 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Abhijit Naik, MD
role: PRINCIPAL_INVESTIGATOR
References: