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Table 1 Baseline clinical characteristics

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

 

Total

(N = 44)

PIO

(N = 14)

EMPA

(N = 16)

PIO + EMPA

(N = 14)

P-value

Demographic and Anthropometric Profile

   

 Age (years)

53.8 (12.5)

49.6 (10.2)

56.3 (10.1)

55.1 (16.4)

0.171

 Male sex (n, %)

24 (54.5)

8 (57.1)

9 (56.2)

7 (50.0)

0.917

 BMI (kg/m2)

28.7 (3.4)

30.4 (3.1)

27.5 (3.0)

28.4 (3.7)

0.050

 Waist circumference (cm)

98 (9)

100 (9)

97 (7)

97 (11)

0.419

 Hypertension (n, %)

23 (52.3)

7 (50.0)

11 (68.8)

5 (35.7)

0.191

 Dyslipidemia (n, %)

42 (95.5)

14 (100.0)

15 (93.8)

13 (92.9)

0.609

 CVD (n, %)

19 (43.2)

3 (21.4)

10 (62.5)

6 (42.9)

0.077

 Systolic blood pressure (mmHg)

128 (10)

124 (10)

128 (11)

130 (8)

0.383

 Diastolic blood pressure (mmHg)

78 (8)

78 (6)

79 (10)

79 (7)

0.859

 Duration of diabetes (yr)a

7.0 [4.0, 14.0]

4.0 [3.0, 6.5]

11.5 [6.3, 18.0]

9.0 [4.2, 12.8]

0.073

Glucometabolic Profile

     

 Fasting glucose (mg/dL)a

164 [146, 193]

148 [138, 161]

171 [136, 198]

178 [163, 197]

0.047

 Fasting insulin (μU/mL)a

13.4 [8.7, 20.6]

20.3 [12.1, 23.9]

10.5 [9.1, 14.1]

12.0 [7.2, 17.9]

0.096

 HbA1c (%)

8.2 (0.8)

8.0 (0.6)

8.5 (1.0)

8.4 (0.6)

0.155

 HOMA-β (%)a

44.1 [23.1, 75.8]

77.6 [42.9, 101.0]

39.4 [23.1, 63.2]

39.0 [21.6, 64.0]

0.049

 HOMA-IR (mg/dL*μIU/mL)a

5.3 [3.8, 8.1]

6.5 [4.7, 8.7]

4.6 [3.2, 6.0]

4.7 [3.2, 8.3]

0.300

 Adiponectin (μg/mL)a

2.6 [2.1, 3.9]

2.5 [2.2, 3.6]

2.6 [2.1, 3.5]

3.6 [1.8, 4.1]

0.713

 Leptin (ng/mL)a

6.4 [3.2, 10.1]

5.5 [3.1, 10.6]

6.7 [4.1, 8.2]

7.1 [3.4, 13.9]

0.857

Body Composition Variable

     

 Visceral fat area (cm2)a

186 [154, 214]

175 [156, 243]

197 [159, 210]

183 [138, 199]

0.777

 Subcutaneous fat area (cm2)

191 (79)

213 (74)

167 (72)

197 (88)

0.286

MASLD-Related Parameter

     

 AST (IU/L)

36 (18)

35 (10)

33 (22)

42 (22)

0.411

 ALT (IU/L)a

49 [29, 61]

55 [49, 59]

31 [21, 59]

44 [35, 70]

0.207

 ALP (IU/L)a

66 [58, 76]

69 [56, 80]

67 [64, 76]

64 [58, 75]

0.577

 GGT (IU/L)a

50 [37, 68]

47 [36, 60]

51 [42, 59]

55 [22, 89]

0.916

 Hepatic steatosis indexa

42.0 [38.9, 46.6]

47.5 [42.7, 49.3]

40.0 [38.3, 42.8]

40.5 [39.5, 44.4]

0.012

 FIB-4 index

1.39 (1.24)

1.45 (1.36)

1.49 (1.58)

1.21 (0.50)

0.818

 Liver fat by MRI-PDFF (%)a

15 [11, 22]

15 [10, 20]

19 [13, 23]

14 [13, 26]

0.593

 Liver stiffness by MRE (kPa)a

2.15 [1.70, 2.40]

2.20 [1.80, 2.85]

2.15 [1.69, 2.35]

2.15 [1.70, 2.35]

0.653

Antidiabetic Medication Use

     

 Metformin (n, %)

44 (100.0)

14 (100.0)

16 (100.0)

14 (100.0)

NA

 Dose of metformin (mg/d)

1000 [1000, 1700]

1000 [1000, 1500]

1000 [1000, 1700]

1500 [1000, 1700]

0.467

 Sulfonylurea (n, %)b

10 (22.7)

5 (35.7)

3 (18.8)

2 (14.3)

0.358

 DPP-4i (n, %)b

37 (84.1)

11 (78.6)

15 (93.8)

11 (78.6)

0.416

 Insulin (n, %)b

10 (22.7)

2 (14.3)

7 (43.8)

1 (7.1)

0.038

  1. Data are described as mean (standard deviation), median [interquartile range], or number (%)
  2. Bolds represent statistically significant values (p < 0.05)
  3. ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase; BMI body mass index, CVD cardiovascular disease, DPP-4i dipeptidyl peptidase-4 inhibitor; 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
  4. aKruskal–Wallis test was performed for non-normal distributions; otherwise, differences among the three groups for continuous variables were analyzed using one-way analysis of variance for normal distributions
  5. bFisher’s exact test was performed for categorical variables, when more than 20% of categories had an expected frequency of less than 5; otherwise, the Chi-square test was used