Glomerular Disease, Kidney Transplant, Kidney Transplant; Complications, Weight Gain
Conditions
Keywords
Caloric Intake Reduction, Dietician
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.
Interventions
BEHAVIORALcaloric 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).
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Podocyte Hypertrophic Stress Between the Intervention and the Control Arm | 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 |
| Difference in the Number of Glomerular Ki67 Positive Cells Between the Intervention and the Control Arm | 3 months | 3 month protocol biopsies will be stained with monoclonal antibodies against Ki67 to identify actively dividing cells and counted manually. |
| Difference in the Number of Glomerular DAPI Positive (Nuclei) Between the Intervention and the Control Arm | 3 months | 3 month protocol biopsies will be stained with monoclonal antibodies against DAPI to identify nucleated cells in the glomerulus and counted manually. |
| Difference in the Number of TLE4 Positive (Podocyte Nuclei) Between the Intervention and the Control Arm | 3 months | 3 month protocol biopsies will be stained with monoclonal antibodies against TLE4 to identify podocytes and counted manually. |
| Differences in Podocyte Detachment Rate Between the Intervention and the Control Arm | 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 |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Proteinuria Between the Intervention and the Control Arm | Measured through study completion, about 3 months | Proteinuria measured by laboratory samples |
| Difference in Glycosylated Hemoglobin (HbA1c) Percent in the Intervention and the Control Arms | 3 months | Measure the difference in HbA1c between the two arms during 3 month protocol biopsies |
| Difference in Weight of Participants in the Intervention and Control Arms | 3 months | Weight as measured by pounds |
| Difference in Glomerular Filtration Rate (GFR) at 3 and 12 Months Between the Intervention and the Control Arm | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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). | 1 |
| 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. | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Total | Caloric Intake Reduction | Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
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
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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.
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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.
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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.
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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
Time frame: 3 months, 12 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
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
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Secondary
Difference in Proteinuria Between the Intervention and the Control Arm
Proteinuria measured by laboratory samples
Time frame: Measured through study completion, about 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.
Secondary
Difference in Weight of Participants in the Intervention and Control Arms
Weight as measured by pounds
Time frame: 3 months
Population: Because only one participant was involved in the entire trial, showing data could violate privacy interests. Further since the outcome measure was to compare the intervention against a control, given that there is no control arm, such a comparison is impossible.