Reduced Calorie Diet Intervention in Kidney Transplant Recipients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): reduced calorie diet
Intervention type(s): Other
Intervention description(s): 10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment