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Table 2 Changes from baseline to week 24 in clinical parameters

From: Synergistic benefit of thiazolidinedione and sodium-glucose cotransporter 2 inhibitor for metabolic dysfunction-associated steatotic liver disease in type 2 diabetes: a 24-week, open-label, randomized controlled trial

 

PIO

(N = 14)

EMPA

(N = 16)

PIO + EMPA

(N = 14)

 

Pre

Post

Post–Pre

P- value*

Pre

Post

Post–Pre

P-value*

Pre

Post

Post–Pre

P-value*

P-value for three group difference for Post–Pre values#

Anthropometrics

             

 BMI (kg/m2)

30.4 [28.9, 32.3]

31.3 [27.1, 32.7]

0.6 [-0.4, 1.2]

0.442

26.7 [25.4, 29.4]

25.9 [24.2, 27.7]

-1.6 [-1.8, -1.0]

< 0.001

28.0 [25.8, 30.3]

28.1 [25.0, 30.1]

-0.1 [-0.1, 0.6]

0.485

0.003

 Body weight (kg)

84 [78, 89]

84 [75, 89]

2 [-1, 3]

0.414

75 [68, 85]

72 [65, 81]

-4 [-5, -3]

< 0.001

76 [67, 85]

76 [68, 84]

-0.4 [-3, 1]

0.583

0.002

 Waist circumference (cm)

101 [92, 108]

99 [94, 107]

0.8 [-1, 2]

0.550

97 [91, 103]

95 [89, 98]

-2 [-3, -2]

< 0.001

98 [89, 103]

95 [88, 108]

0 [-3, 1]

0.449

0.018

 Systolic blood pressure (mmHg)

128 [119, 131]

125 [121, 127]

-3 [-4, 5]

0.753

130 [124, 134]

124 [113, 134]

-6 [-9, 1]

0.050

129 [125, 133]

126 [115, 134]

-5 [-12, 7]

0.489

0.528

 Diastolic blood pressure (mmHg)

78 [74, 82]

78 [71, 80]

-1 [-11, 7]

0.509

80 [72, 87]

80 [77, 84]

-2 [-6, 2]

0.572

77 [75, 84]

77 [75, 81]

-1 [-9, 4]

0.600

0.991

Glucometabolic Profile

             

 Fasting glucose (mg/dL)

148 [138, 161]

126 [112, 134]

-22 [-35, -18]

0.001

171 [136, 198]

114 [92, 126]

-53 [-77, -35]

< 0.001

178 [163, 197]

119 [112, 132]

-57 [-69, -41]

< 0.001

0.007

 Fasting insulin (μU/mL)

20.3 [12.1, 23.9]

9.3 [8.2, 14.9]

-8.1 [-11.8, -1.2]

0.009

10.5 [9.1, 14.1]

7.8 [5.4, 14.8]

-2.9 [-6.4, 0.3]

0.074

12.0 [7.2, 17.9]

6.1 [3.7, 9.8]

-4.4 [-7.9, -2.5]

0.002

0.195

 HbA1c (%)

7.9 [7.6, 8.2]

6.7 [6.2, 6.8]

-1.3 [-1.8, -0.5]

0.003

8.4 [7.9, 9.3]

7.3 [6.4, 7.8]

-1.3 [-2.5, -0.1]

0.010

8.4 [8.2, 8.6]

6.8 [6.3, 7.2]

-1.5 [-2.0, -1.2]

0.002

0.763

 HOMA-β (%)

77.6 [42.9, 101.0]

67.6 [48.0, 81.5]

-3.8 [-44.1, 17.2]

0.300

39.4 [23.1, 63.2]

82.4 [41.4, 101.0]

23.7 [8.1, 48.5]

0.015

39.0 [21.6, 64.0]

47.9 [24.1, 70.8]

3.1 [-3.9, 8.4]

0.221

0.026

 HOMA-IR (mg/dL*μIU/mL)

6.5 [4.7, 8.7]

3.0 [2.3, 4.9]

-3.2 [-5.0, -1.5]

0.002

4.6 [3.2, 6.0]

2.3 [1.1, 4.0]

-2.8 [-3.4, -0.8]

0.003

4.7 [3.2, 8.3]

1.9 [1.2, 2.7]

-2.7 [-5.7, -1.5]

0.001

0.499

 Adiponectin (μg/mL)

2.5 [2.2, 3.6]

10.1 [7.0, 13.7]

7.0 [4.7, 8.7]

 < 0.001

2.6 [2.1, 3.5]

7.0 [5.8, 11.4]

4.2 [2.8, 7.6]

< 0.001

3.6 [1.8, 4.1]

14.8 [9.8, 18.6]

10.1 [6.6, 14.9]

< 0.001

0.036

 Leptin (ng/mL)

5.5 [3.1, 10.6]

8.0 [2.7, 10.4]

0.2 [-1.6, 4.1]

0.626

6.7 [4.1, 8.2]

5.4 [2.8, 6.8]

-1.3 [-2.6, -0.2]

0.211

7.1 [3.4, 13.9]

6.5 [3.4, 11.2]

-0.8 [-3.4, 1.9]

0.583

0.436

Body Composition Variable

             

 Visceral fat area (cm2)

175 [156, 243]

177 [142, 213]

-7 [-33, 1]

0.091

197 [159, 210]

160 [145, 172]

-30 [-44, -26]

< 0.001

183 [138, 199]

140 [96, 169]

-34 [-46, -19]

< 0.001

0.088

 Subcutaneous fat area (cm2)

204 [175, 250]

205 [149, 301]

16 [8, 38]

0.042

152 [129, 180]

130 [113, 171]

-11 [-19, -4]

0.004

181 [137, 253]

190 [123, 290]

-3 [-14, 33]

0.780

0.007

MASLD-Related Parameter

             

 AST (IU/L)

34 [28, 44]

24 [18, 33]

-9 [-14,-1]

0.045

25 [18, 48]

20 [16, 28]

-4 [-18, 1]

0.112

39 [26, 50]

20 [17, 23]

-15 [-31, -10]

0.001

0.049

 ALT (IU/L)

55 [49, 59]

34 [23, 45]

-19 [-26, -6]

0.001

31 [21, 59]

21 [17, 39]

-10 [-28, -1]

0.033

44 [35, 70]

17 [15, 27]

-22 [-39, -12]

< 0.001

0.161

 ALP (IU/L)

69 [56, 80]

60 [49, 70]

-7 [-14, -6]

0.017

67 [64, 76]

60 [55, 73]

-4 [-12, 0]

0.021

64 [58, 75]

57 [52, 64]

-7 [-12, -2]

0.055

0.490

 GGT (IU/L)

47 [36, 60]

25 [24, 39]

-15 [-34, -9]

0.002

51 [42, 59]

28 [20, 39]

-13 [-28, -5]

0.007

55 [22, 89]

24 [16, 38]

-29 [-53, -7]

0.002

0.281

 Hepatic steatosis index

47.5 [42.7, 49.3]

43.2 [39.7, 47.7]

-1.6 [-3.7, -0.5]

0.025

40.0 [38.3, 42.8]

37.1 [35.5, 39.0]

-2.9 [-4.6, -1.3]

< 0.001

40.5 [39.5, 44.4]

39.9 [36.0, 43.8]

-4.5 [-5.5, 0.2]

0.049

0.706

 FIB-4 index

0.94 [0.67, 1.71]

1.04 [0.56, 1.77]

0.02 [-0.15, 0.15]

0.952

1.02 [0.82, 1.53]

1.07 [0.80, 1.25]

0.01 [-0.26, 0.10]

0.660

1.08 [0.95, 1.47]

0.96 [0.64, 1.45]

-0.20 [-0.32, -0.03]

0.025

0.230

 Liver fat by MRI-PDFF (%)

15 [10, 20]

12 [4, 17]

-7 [-10, -3]

0.025

19 [13, 23]

8 [5, 12]

-9 [-12, -5]

0.001

14 [13, 26]

4 [3, 9]

-10 [-12, -9]

0.001

0.063

 Liver stiffness by MRE (kPa)

2.20 [1.80, 2.85]

1.95 [1.72, 2.45]

-0.25 [-0.50, 0.00]

0.034

2.15 [1.69, 2.35]

2.05 [1.78, 2.42]

0.00 [-0.40, 0.12]

0.530

2.15 [1.70, 2.35]

1.70 [1.52, 2.03]

-0.35 [-0.60, 0.00]

0.015

0.210

  1. Bolds represent statistically significant values (p < 0.05)
  2. ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, CVD cardiovascular disease, EMPA empagliflozin, FIB-4 fibrosis index based on 4 factors, GGT gamma-glutamyl transferase, HbA1c glycated haemoglobin A1c, HOMA-β homeostasis model assessment of β-cell function, HOMA-IR homeostatic model assessment of insulin resistance, MASLD metabolic dysfunction-associated steatotic liver disease; MRE magnetic resonance elastography, MRI-PDFF magnetic resonance imaging-proton density fat fraction, PIO pioglitazone
  3. #P-value of Kruskal–Wallis test for the difference between three groups
  4. *Wilcoxon signed-rank test was performed
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BMC Medicine

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