Nonrandomized Trial of Weight Loss With Orlistat, Nutrition Education, Diet, and Exercise in Obese Patients With CKD: 2-Year Follow-up

Background: Obesity increases the comorbidity-adjusted relative risk of developing end-stage renal disease. Body mass index (BMI) > 30 kg/m(2) was a contraindication for transplant in our renal unit until 2008. Study Design: Open-label prospective nonrandomized intervention. Setting & Participants: All men and women aged 18-75 years with chronic kidney disease (CKD) and BMI > 30 or > 28 kg/m(2) with diabetes, hypertension, or dyslipidemia and otherwise suitable for kidney transplant if on dialysis therapy were eligible to enroll in the weight-management program. 64 patients were referred; 44 agreed to participate in the intervention group and 20 did not wish to take part and constitute the usual-care group. Intervention: 24-month weight-management program that included a low-fat renal-specific diet, exercise, and orlistat, 120 mg, 3 times daily. Outcomes: Body weight, blood pressure (BP), kidney transplant wait listing. Measurements: Body weight, BP, estimated glomerular filtration rate (eGFR; calculated using the 4-variable Modification of Diet in Renal Disease [MDRD] Study equation). Results: 32 patients (73%) in the weight-management program group completed the follow-up evaluation. Baseline mean BMI was 35.7 +/- 4.5 (SD) kg/m(2) in the weight-management program group and 34.1 +/- 4.2 kg/m(2) in the usual-care group. 12 (38%) patients in the weight-management program and 9 (45%) in usual care had stages 3-4 CKD, with the remainder in stage 5 CKD on dialysis therapy. There were no differences in body weight, BP, or eGFR between groups at baseline. After 24 months, mean body weight was 94.6 +/- 16.1 kg in the weight-management program group versus 101.0 +/- 26.8 kg in the usual-care group (P < 0.001), and eGFR was 43 mL/min in the weight-management program group versus 18 mL/min in the usual-care group (P < 0.001). 9 of 26 (35%) otherwise eligible patients in the weight-management program and 1 of 18 (6%) patients in usual care were accepted for kidney transplant listing, with 3 transplants performed in the weight-management program group and 1 in the usual-care group. Limitations: Nonrandomized trial, small number of participants. Conclusions: The weight-management program group showed significant weight loss and weight-loss maintenance in obese patients with CKD and potentially enables obese patients with CKD to undergo kidney transplant. Am J Kidney Dis 55: 69-76. (C) 2009 by the National Kidney Foundation, Inc.