Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

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University of Michigan

Status

Terminated

Conditions

Weight Gain
Kidney Transplant; Complications
Kidney Transplant
Glomerular Disease

Treatments

Behavioral: caloric intake reduction

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03607500
HUM00134686
P30DK089503 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

Caloric Intake Reduction
Experimental group
Description:
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.
Treatment:
Behavioral: caloric intake reduction
Standard of care
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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