Table 1 Baseline characteristics.

From: A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes

 

Treatment group

Placebo N = 33

500 mg BID N = 33

1000 mg BID N = 34

Age (years)

 N

33

33

34

 Mean (SD)

58 (10.7)

58 (10.2)

53 (12.2)

 Min, max

40, 75

26, 75

27, 72

Sex–n (%)

 Male

11 (33%)

7 (21%)

10 (29%)

 Female

22 (67%)

26 (79%)

24 (71%)

Race–n (%)

 White

31 (94%)

29 (88%)

31 (91%)

 Black

0

3 (9%)

2 (6%)

 Other

2 (6%)

1 (3%)

1 (3%)

Ethnicity–n (%)

 Hispanic or Latino

13 (39%)

14 (42%)

11 (32%)

 Not Hispanic or Latino

20 (61%)

19 (58%)

23 (68%)

Weight (kg)

 N

33

33

34

 Mean (SD)

97.5 (22.57)

98.4 (23.05)

101.2 (20.26)

 Min, max

70.8, 180

64.9, 154.1

71.7, 159.2

BMI (kg/m2)

 N

33

33

34

 Mean (SD)

35.0 (6.18)

36.7 (6.88)

36.3 (6.28)

 Min, max

25.4, 55.6

26.1, 55.9

25.4, 49.1

Liver fat content (%)*

 N

32

33

34

 Mean (SD)

20.2 (6.23)

18.4 (6.24)

19.4 (6.96)

 Min, max

11.1, 41.7

11.0, 43.48

9.0, 33.7

Corrected T1*

 N

32

32

32

 Mean (SD)

940.8 (99.27)

948.8 (119.53)

932.4 (80.06)

 Min, max

834.0, 1317.0

802.5, 1412.0

837.5, 1122.0

ALT (U/L)

 N

33

33

34

 Mean (SD)

54 (26.7)

46 (27.6)

62 (31.8)

 Median

47

39

55

 Min, max

17, 115

3, 141

24, 143

AST (U/L)

 N

33

33

34

 Mean (SD)

38 (17.3)

36 (15.9)

45 (29.7)

 Median

32

31

37

 Min, max

19, 88

15, 80

19, 147

GGT (U/L)

 N

33

33

34

 Mean (SD)

70 (105.1)

64 (50.7)

68 (57.2)

 Median

38

39

45

 Min, max

19, 618

18, 223

19, 263

HbA1c (%)

 N

33

33

34

 Mean (SD)

7.0 (1.05)

6.9 (0.85)

7.3 (1.16)

 Median

6.9

6.9

7.5

 Min, max

5.3, 9.4

5.5, 9.1

5.1, 9.3

LDL cholesterol (mg/dL)**

 N

33

30

29

 Mean (SD)

99 (35.8)

86 (29.4)

107 (35.3)

 Median

98

81

111

 Min, max

37, 188

26, 150

31, 168

Triglycerides (mg/dL)**

 N

33

31

30

 Mean (SD)

197 (83.3)

190 (204.6)

174 (77.1)

 Min, max

76, 423

54, 1217

58, 430

Fasting insulin (IU/mL)

 N

33

33

34

 Mean (SD)

45.7 (34.64)

30.8 (15.74)

32.9 (16.43)

 Min, max

6.2, 155.4

9.5, 70.7

9.6, 82.4

Fasting plasma glucose (mg/dL)

 N

33

33

34

 Mean (SD)

136 (44.1)

140 (39.9)

155 (46.3)

 Min, max

94, 313

89, 288

90, 268

  1. *Multiparametric MRI assessment.
  2. **Modified efficacy set.