Reduced Calorie Diet Intervention in Kidney Transplant Recipients

Completed · Phase 2

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT00994838

Run by

Vanderbilt University

People needed

27

Starts

2009-10-01

Expected to finish

2014-01-01

Last updated by the study team

2015-07-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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