Reduced Calorie Diet Intervention in Kidney Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Kelly Birdwell, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00994838
First received: October 12, 2009
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • an improvement in insulin resistance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • a decrease in oxidative stress markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • an improvement in kidney function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  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 ClinicalTrials.gov identifier: NCT00994838

Contacts
Contact: Kelly A Birdwell, MD 615-343-8546 kelly.birdwell@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Brianna L Pouliot, RD    615-875-5494    brianna.laderbush@vanderbilt.edu   
Principal Investigator: Kelly A Birdwell, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Kelly A Birdwell, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Kelly Birdwell, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00994838     History of Changes
Other Study ID Numbers: 091030
Study First Received: October 12, 2009
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014