Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

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)

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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.