search
Back to results

Reduced Calorie Diet Intervention in Kidney Transplant Recipients

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
reduced calorie diet
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years to 65 years;
  • BMI 25 to 40 kg/m2;
  • First time kidney transplant;
  • Single organ transplant;
  • Ability to understand and voluntarily provide informed consent.

Exclusion Criteria:

  • Type 1 DM;
  • Type 2 DM on diabetic medications/insulin;
  • Biopsy proven acute rejection in the first 3 months post transplant;
  • Active coronary disease;
  • Immunosuppressive therapy at time of transplant (use prior to what is given for transplant procedure);
  • Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
  • Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

reduced calorie diet

standard diet

Arm Description

10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption

Outcomes

Primary Outcome Measures

a significant improvement in measures of body composition (including weight, BMI, and fat mass)

Secondary Outcome Measures

an improvement in insulin resistance
a decrease in oxidative stress markers
an improvement in kidney function

Full Information

First Posted
October 12, 2009
Last Updated
July 16, 2015
Sponsor
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT00994838
Brief Title
Reduced Calorie Diet Intervention in Kidney Transplant Recipients
Official Title
Reduced Calorie Diet Intervention in Kidney Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to measure the effect of a reduced calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.
Detailed Description
Kidney transplantation is the preferred renal replacement therapy for end stage renal disease (ESRD) because it affords survival and quality of life advantages over maintenance dialysis.1 The number of transplants performed increases each year, with currently over 150,000 individuals living in the United States with a kidney transplant. This is in the setting of 68,000 patients on the wait list with a median wait time of 4 years for an available organ.2 Despite the survival benefit over dialysis, transplanted patients still have a greatly increased risk of cardiovascular disease (CVD) over the general population, and CVD is the leading cause of death among recipients with a functioning graft.3 Given the long wait times for kidneys due to organ shortage, extensive resources used, and support needed for each transplant procedure, it is imperative that we improve long term patient and graft survival. Accordingly, modification of CVD risk profile is of paramount importance in kidney transplant patients. The etiology of increased risk of CVD in kidney transplant patients is multi-factorial and includes the high burden of CVD and its risk factors present prior to transplant, as well as increasing prevalence of these risk factors in the post transplant period due to transplant associated weight gain, immunosuppression side effects, metabolic consequences of a functioning kidney, and allograft dysfunction. Efforts to reduce CVD risk factors have yet to be adequately implemented and rigorously studied in the kidney transplant population. Obesity at the time of transplant is common and associated with several CVD risk factors post transplant, including hypertension, hyperlipidemia, diabetes mellitus, metabolic syndrome, and inflammation. Obesity is also associated with potentially poorer graft outcomes, including death censored graft loss and chronic allograft failure.4 In addition, the majority of patients gain weight post transplantation, primarily in the form of fat mass. Post transplant weight gain is also associated with increased prevalence of known CVD risk factors, CVD death, and graft loss.5 The increased burden of CVD in kidney transplant patients makes obesity prevention and treatment strategies appealing interventions to improve long-term outcomes, both in terms of graft and overall survival. In this study we will measure the effect of a low calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
reduced calorie diet
Arm Type
Active Comparator
Arm Description
10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
Arm Title
standard diet
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
reduced calorie diet
Intervention Description
10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
Primary Outcome Measure Information:
Title
a significant improvement in measures of body composition (including weight, BMI, and fat mass)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
an improvement in insulin resistance
Time Frame
12 months
Title
a decrease in oxidative stress markers
Time Frame
12 months
Title
an improvement in kidney function
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years to 65 years; BMI 25 to 40 kg/m2; First time kidney transplant; Single organ transplant; Ability to understand and voluntarily provide informed consent. Exclusion Criteria: Type 1 DM; Type 2 DM on diabetic medications/insulin; Biopsy proven acute rejection in the first 3 months post transplant; Active coronary disease; Immunosuppressive therapy at time of transplant (use prior to what is given for transplant procedure); Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity); Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly A Birdwell, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Reduced Calorie Diet Intervention in Kidney Transplant Recipients

We'll reach out to this number within 24 hrs