Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

Weight Gain Clinical Trial

Official title:

Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03607500
• Other study ID #: HUM00134686
• Secondary ID: P30DK089503
• Status: Terminated
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: August 16, 2021

Study information

• Verified date: January 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Difference in Proteinuria Between the Intervention and the Control Arm	Proteinuria measured by laboratory samples	Measured through study completion, about 3 months
Secondary	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
Secondary	Difference in Weight of Participants in the Intervention and Control Arms	Weight as measured by pounds	3 months