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Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT03607500
Recruitment Status : Suspended (Lack of funding)
First Posted : July 31, 2018
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abhijit Naik, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Glomerular Disease Weight Gain Kidney Transplant Behavioral: caloric intake reduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 ]
  2. Difference in the number of glomerular Ki67 positive cells between the intervention and the control arm [ Time Frame: 3 months ]
    3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually.

  3. Difference in the number of glomerular DAPI positive (nuclei) between the intervention and the control arm [ Time Frame: 3 months ]
    3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually.

  4. Difference in the number of TLE4 positive (podocyte nuclei) between the intervention and the control arm [ Time Frame: 3 months ]
    3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually.

  5. Differences in podocyte detachment rate between the intervention and the control arm [ Time Frame: 3 months ]
    Urine samples obtained at the time of 3-month protocol biopsies will be utilized to compare the urinary podocin mRNA to urinary creatinine ratio

  6. Difference in the podocyte hypertrophic stress between the intervention and the control arm [ Time Frame: 3 months ]
    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 :
  1. Difference in glomerular filtration rate (GFR) at 3 and 12 months between the intervention and the control arm [ Time Frame: 3 months, 12 months ]
    Differences in glomerular filtration rate (GFR) using both creatinine (modified diet in renal disease) as well as serum cystatin C based equations

  2. Difference in Proteinuria between the intervention and the control arm [ Time Frame: Measured through study completion, about 3 months ]
    Proteinuria measured by laboratory samples

  3. Difference in Glycosylated hemoglobin (HbA1c) percent in the intervention and the control arms [ Time Frame: 3 months ]
    Measure the difference in HbA1c between the two arms during 3 month protocol biopsies

  4. Difference in weight of participants in the intervention and control arms [ Time Frame: 3 months ]
    Weight as measured by pounds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607500


Locations
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United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Abhijit Naik, MD University of Michigan
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Responsible Party: Abhijit Naik, Assistant Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03607500    
Other Study ID Numbers: HUM00134686
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abhijit Naik, University of Michigan:
Caloric Intake Reduction
Dietician
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight