Status:
COMPLETED
Reduced Calorie Diet Intervention in Kidney Transplant Recipients
Lead Sponsor:
Vanderbilt University
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00994838
Start Date
October 1 2009
End Date
January 1 2014
Last Update
July 17 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232