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Table 1 Baseline characteristics of the study population (n = 395)

From: Efficacy and durability of multifactorial intervention on mortality and MACEs: a randomized clinical trial in type-2 diabetic kidney disease

Parameter SoC (n = 188) Intervention (n = 207) p SDiff (%)
Male Sex, No. (%) 83(44.1) 103 (49.8) 0.382 11.3
Age, mean (SD), y 68.2 (8.8) 66.1 (9) 0.046 24.1
BMI (kg/m2), mean (SD) 29.4 (4.9) 28.5 (4.7) 0.288 19.1
Blood pressure (mmHg), mean (SD)     
 Systolic 134.7 (12.6) 133.8 (14.3) 0.791 6.1
 Diastolic 78.3 (7.7) 80.8 (7.4) 0.002 − 32.8
Systolic BP target, No. (%) 95 (50.5) 112 (54.1) 0.142 − 17.0
Diastolic BP target, No. (%) 150 (79.8) 136 (65.7) 0.274 19.2
Blood Pressure Target, No. (%) 90 (47.9) 105 (55.3) 0.193 − 14.8
Creatinine (mg/dL), mean (SD) 1.16 (0.5) 1.17 (0.5) 0.564 − 1.4
eGFR EPI-CKD (mL/min/m2), mean (SD) 62.7 (21.2) 65.4 (23) 0.350 − 12.1
eGFR EPI-CKD stage, No. (%)     
 1 20 (10.6) 45 (21.7) 0.600 − 31.1
 2 80 (42.6) 77 (37.2)   
 3 76 (40.4) 71 (34.3)   
 4 10 (5.3) 11 (5.3)   
 5 2 (1.1) 3 (1.5)   
Albuminuria (mg/day), median [IQR] 57.3 [35—158.1] 120.5 [75.8 – 223.8] 0.115 − 25.2
Haemoglobin (mg/dL), mean (SD) 13.4 (1.3) 12.9 (1.5) 0.377 36.8
Glycemia (mg/dL), mean (SD) 152.7 (49) 155.9 (43.1) 0.924 − 6.9
HbA1c (%), mean (SD) 7.3 (1.1) 7.5 (1.1) 0.345 − 18.2
HbA1c Target, No. (%) 100(53.2) 66 (31.9) 0.001 43.1
Diabetes duration, median [IQR], y 9 (6–15) 9 (7–16) 0.801 − 11.4
Cholesterol (mg/dL), mean (SD)     
 Total 185.8 (34.1) 187.6 (33.2) 0.688 − 5.5
 LDL 111.5 (30.8) 107.5 (27) 0.703 13.7
Total Cholesterol Target, No. (%) 67 (35.6) 64 (30.9) 0.475 5.6
HDL Cholesterol Target, No. (%) 99 (52.7) 75 (36.2) 0.237 14.5
LDL Cholesterol Target, No. (%) 73 (38.8) 69 (33.3) 0.911 6.2
Triglycerides (mg/dL), median (IQR) 111 (88 – 153) 148 (115 – 190) 0.063 − 42.7
Therapy     
Anti-hypertensive Therapy, No. (%)    0.791 − 24.8
 1 105 (55.9) 94 (45.4)   
 2 20 (10.6) 31 (15)   
 3 32 (17) 44 (21.3)   
 4 18 (9.6) 27 (13)   
 5 13 (6.9) 11 (5.3)   
ACEi/ARBs, No. (%)     
 ACEi 119 (63.2) 125 (60.2) 0.748 −  25.6
 ARBs 66 (35.4) 77 (37.4)   
 ACE + ARBs 3 (1.4) 5 (2.4)   
Diuretics, No. (%) 83 (44.1) 113 (54.6) 0.840 − 21.0
Calcium Channel Blockers, No. (%) 63 (33.5) 82 (39.6) 0.792 − 12.7
Beta-blockers, No. (%) 31 (16.5) 38 (18.4) 0.655 − 4.9
Alpha-blockers, No. (%) 13 (6.9) 11 (5.3) 0.395 6.7
Diabetes Therapy, No. (%)    0.361 − 27.7
 Diet 16 (8.5) 5 (2.4)   
 Insulin 50 (26.6) 60 (29)   
 Oral anti-hyperglycemics* 97 (51.6) 108 (52.2)   
 Combined Therapy 25 (13.3) 33 (15.9)   
 Missing 0 (–) 1 (0.5)   
Statins, No. (%)    0.569 − 10.8
 Yes 72 (38.3) 89 (43)   
 Missing 0 (–) 3 (1.4)   
Antiplatelets, No. (%)    0.057 − 58.8
 Yes 71 (37.8) 126 (60.9)   
 Missing 0 (–) 16 (7.7)   
  1. p-values were computed by generalized estimating equations (GEE) model with cluster as group variable
  2. BMI Body Mass Index, BP Blood Pressure, GFR Glomerular Filtrate, HbA1c Glycated haemoglobin, IQR interquartile range, SD standard deviation, ACEi Angiotensin-Converting-Enzyme inhibitor, ARBs Angiotensin II receptor blockers
  3. *Metformin, Pioglitazone, acarbose, etc