Franny Jongbloed

170 CHAPTER 7 RESULTS Study population Of the 45 living kidney donors that were included initially and who underwent randomization, 30 were equally distributed (n = 10) in the three groups and completed the study. Of the 54 morbidly obese patients that were included initially, 38 were distributed in the three groups with 18 patients in the restricted diet group, 10 in the DER-diet group, and 10 in the control group (Figure S1). At baseline, the morbidly obese patients group had significantly higher average body weight and BMI and was significantly more often female (Table 1). There were no differences in the baseline characteristics after randomization between dropouts and patients who completed the study. Table 1. Baseline characteristics of the study population Parameter Living Kidney Donors ( n = 30) Morbidly Obese Patients ( n = 38) P- Value Age, years 47 ± 13 43 ± 9 0.17 Gender, F/M 12/18 31/7 0.003 Body weight, kg 82.8 ± 17.3 129.1 ± 24.6 <0.001 BMI, kg/m 2 26.6 ± 4.6 44.5 ± 5.4 <0.001 Baseline characteristics of the study population; Values are depicted as mean ± standard deviation; Significant P- values are depicted in bold; At baseline, the morbidly obese patients group had a significantly higher average body weight and BMI and were significantly more often female. F=female; M=male; BMI= body mass index. Compliance with the diets by kidney donors and morbidly obese patients A total of 10 living kidney donors and 18 morbidly obese patients were randomized into the restricted diet group. This group received a synthetic diet with a mean calorie restriction of 30% and a mean protein restriction of 80% relative to each patient’s DER. Twenty individuals (71%) reported completing the five-day diet (Figure S2). Eight out of 10 kidney donors (80%), and 12 out of 18 morbidly obese patients (67%) reported completing the restricted diet. Ten donors and 10 morbidly obese patients were randomized into the DER-diet. This group received a synthetic diet which resulted in a mean DR of 4% without PR. Thirteen out of 20 (65%) individuals receiving this diet reported completing the diet. Of the kidney donors, four out of 10 (40%) completed the diet; nine out of 10 (90%) morbidly obese patients completed the diet (Figure S2).