Skip to main content

Table 1 Baseline characteristics of subjects (full analysis set)

From: Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study

Variable

Be

Bi

BB

Placebo

P value

n (%)

49 (98.00)

100 (100.00)

49 (98.00)

99 (99.00)

 

Age, years

53.28 ± 9.87

54.16 ± 9.10

53.36 ± 9.49

52.73 ± 9.35

0.761

Sex (male), n (%)

23 (46.94)

59 (59.00)

27 (55.10)

54 (54.55)

0.585

BW, kg

68.37 ± 10.82

69.57 ± 9.06

69.04 ± 10.48

69.58 ± 11.24

0.904

BMI, kg/m2

25.05 ± 2.68

25.25 ± 2.28

25.20 ± 2.69

25.02 ± 2.80

0.921

Waist circumference, cm

90.08 ± 9.25

90.98 ± 7.58

91.82 ± 8.13

91.13 ± 8.58

0.774

Hip circumference, cm

98.17 ± 5.73

98.72 ± 7.74

98.60 ± 6.20

98.10 ± 6.81

0.920

Systolic blood pressure, mmHg

120.56 ± 11.88

123.08 ± 12.42

121.17 ± 13.75

122.71 ± 11.37

0.591

Diastolic blood pressure, mmHg

77.46 ± 8.94

78.57 ± 8.19

77.97 ± 7.82

76.86 ± 7.68

0.516

Pulse, beats/min

73.14 ± 8.29

74.15 ± 8.56

74.80 ± 7.20

74.17 ± 9.18

0.812

ECG

    

0.225

 Normal, n (%)

39 (79.59)

64 (64.00)

29 (59.18)

63 (63.64)

 

 Non-clinical significance, n (%)

9 (18.37)

33 (33.00)

17 (34.69)

26 (26.26)

 

 Clinical significance, n (%)

1 (2.04)

3 (3.00)

3 (6.12)

9 (9.09)

 

 None, n (%)

0 (0.00)

0 (0.00)

0 (0.00)

1 (1.01)

 

FPG, mmol/L

6.49 ± 0.64

6.40 ± 0.66

6.42 ± 0.77

6.43 ± 0.71

0.881

30 min post-plasma glucose, mmol/L

12.12 ± 1.63

11.93 ± 1.84

11.76 ± 2.09

11.94 ± 1.86

0.830

2-hr PPG, mmol/L

11.17 ± 2.41

11.40 ± 3.08

11.24 ± 2.37

11.62 ± 3.08

0.906

HbA1c, %

6.19 ± 0.53

6.19 ± 0.59

6.12 ± 0.72

6.23 ± 0.68

0.920

Fasting serum insulin, μIU/mL

9.87 (5.91–13.60)

10.52 (7.65–13.88)

9.56 (7.49–13.89)

9.78 (6.69–11.98)

0.430

30 min post-serum insulin, μIU/mL

39.16 (21.46–64.74)

33.00 (19.75–61.83)

34.30 (20.40–51.74)

32.98 (23.88–52.84)

0.962

2-hr post-serum insulin, μIU/mL

61.85 (40.88–94.43)

58.56 (40.50–84.36)

69.15 (46.19–88.76)

56.26 (36.35–79.12)

0.279

Fasting serum C peptide, ng/mL

1.46 (0.60–2.04)

1.58 (0.60–2.28)

1.38 (0.72–2.13)

1.47 (0.63–2.13)

0.995

30 min post-serum C peptide, ng/mL

3.29 (2.07–4.44)

2.67 (1.52–3.87)

2.76 (1.77–3.84)

2.79 (1.08–4.53)

0.711

2-hr post-serum C peptide, ng/mL

6.01 (3.09–8.92)

5.64 (2.16–8.74)

6.76 (3.39–8.35)

5.82 (2.40–8.32)

0.745

TG, mmol/L

2.12 (1.50–2.61)

1.71 (1.21–2.46)

1.66 (1.03–2.14)

1.83 (1.20–2.35)

0.253

TC, mmol/L

5.03 ± 1.15

4.76 ± 1.01

4.44 ± 0.96

4.72 ± 0.88

0.035

HDL-C, mmol/L

1.15 ± 0.30

1.19 ± 0.31

1.12 ± 0.27

1.15 ± 0.26

0.535

LDL-C, mmol/L

3.00 ± 0.88

2.85 ± 0.80

2.67 ± 0.84

2.81 ± 0.79

0.260

HOMA-IR

2.69 (1.76–3.41)

3.05 (1.88–4.08)

2.74 (2.16–3.95)

2.75 (1.89–3.45)

0.450

HOMA-β

69.66 (42.97–98.37)

71.98 (53.23–105.48)

68.00 (46.41–96.77)

63.53 (48.40–87.79)

0.832

Fasting GLP-1, pmol/L

2.38 (1.64–5.24)

2.00 (1.53–5.11)

2.95 (1.52–5.82)

2.71 (1.66–5.99)

0.895

30 min post-GLP-1, pmol/L

4.39 (2.71–7.03)

4.62 (2.62–7.29)

3.77 (2.62–7.28)

3.98 (2.37–6.97)

0.982

2-hr post-GLP-1, pmol/L

2.31 (1.24–4.34)

2.48 (1.80–5.04)

3.32 (1.92–5.32)

2.48 (1.40–5.04)

0.745

Area under the curve of GLP-1

7.48 (4.53–14.40)

8.13 (4.91–12.90)

6.99 (5.31–13.69)

6.95 (4.72–13.34)

0.905

  1. Data were presented as n (%), mean ± standard deviation, and median (range interquartile). P value: comparison among the groups after treatment
  2. ECG explanation: normal, normal ECG; non-clinical significance, abnormal ECG without any clinical significance; clinical significance, abnormal ECG with clinical significance; none, ECG was not performed
  3. HOMA-IR: (fasting serum insulin × fasting plasma glucose)/22.5, homeostasis model assessment index for assessing insulin resistance; HOMA-β: (20 × fasting serum insulin)/(fasting plasma glucose − 3.5), homeostasis model assessment index for assessing β cell function. P value: comparison among the groups; Be: treatment with berberine; Bi: treatment with Bifidobacterium; BB: treatment with berberine and Bifidobacterium
  4. BW body weight, BMI body mass index, FPG fasting plasma glucose, 2-hr PPG 2-hour postprandial plasma glucose, TG triglyceride, TC total cholesterol, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, ECG electrocardiogram