Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Reduced Calorie Diet Intervention in Kidney Transplant Recipients

This study has been completed.
Information provided by (Responsible Party):
Kelly Birdwell, Vanderbilt University Identifier:
First received: October 12, 2009
Last updated: July 16, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Chronic Kidney Disease
Other: reduced calorie diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduced Calorie Diet Intervention in Kidney Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • a significant improvement in measures of body composition (including weight, BMI, and fat mass) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • an improvement in insulin resistance [ Time Frame: 12 months ]
  • a decrease in oxidative stress markers [ Time Frame: 12 months ]
  • an improvement in kidney function [ Time Frame: 12 months ]

Enrollment: 27
Study Start Date: October 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: reduced calorie diet
10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
Other: reduced calorie diet
10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
No Intervention: standard diet

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00994838

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Kelly A Birdwell, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Kelly Birdwell, Assistant Professor, Vanderbilt University Identifier: NCT00994838     History of Changes
Other Study ID Numbers: 091030
Study First Received: October 12, 2009
Last Updated: July 16, 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on May 23, 2017