Table 3 Comparison of clinical and biochemical variables at baseline and at the end of the study in the different arms (intention to treat analysis)

BMI (SDS)

2.33 ± 0.57

1.89 ± 0.45***

2.23 ± 0.57

1.99 ± 0.56^*°

2.29 ± 0.77

2.21 ± 0.73°°°

Acanthosis nigricans, n (%)

8 (13.8)¹

3 (5.1)***

6 (13.3)

6 (13.3)

5 (13.1)²

4 (10.5)

IGT

7 (12.1)¹

4 (6.9)*

5 (11.1)

4 (8.8)

4 (10.5)

3 (8.6)

T2DM

2 (3.4)

1 (1.7)

1 (2.2)

1 (2.2)

1 (2.6)²

1 (2.6)

Fasting glucose, mg/dL

91.23 ± 4.39

86.34 ± 4.69***

89.63 ± 3.17

86.72 ± 6.00^§§§

90.12 ± 5.79

91.36 ± 2.98°°°

Fasting insulin, μU/mL

27.48 ± 7.92

20.23 ± 5.12***

26.71 ± 9.36

22.09 ± 3.67**^§§§

27.46 ± 8.55

25.32 ± 4.19°°°

HbA1c, %, mmol/mol

5.66 ± 0.57

5.43 ± 0.39**

5.70 ± 0.52

5.40 ± 0.51*

5.69 ± 0.59

5.54 ± 0.50

HOMA-IR, mean (range)

5.76 (3.60–10.67)

3.73 (2.64–7.13)**

5.68 (2.00–10.90)

4.90 (3.15–6.26)*°°^§§

5.76 (3.21–8.89)

5.63 (3.11–6.37)°°

IS_OGTT, SDS

1.42 ± 0.26

3.01 ± 0.85***

1.42 ± 0.22

1.74 ± 0.40***°°

1.58 ± 0.49

1.43 ± 0.21*°°°

Insulinogenic index, mean (range)

3.61 (1.70–9.25)

2.86 (1.84–6.78)*

2.54 (1.91–10.2)^##

2.40 (0.82–5.87)

3.07 (1.13–9.70)

2.82 (1.13–7.05)

Disposition index, mean (range)

4.48 (2.22–12.02)

9.13 (5.01–21.65)***

4.01 (0.83–11.72)

4.93 (1.53–7.27)*°°°

3.80 (1.88–14.78)

4.14 (1.42–5.98)°°°

Total cholesterol (mmol/L)

4.38 ± 0.52

3.63 ± 0.68***

4.36 ± 1.09

3.58 ± 0.93**

4.49 ± 0.80

3.67 ± 0.62**

LDL cholesterol (mmol/L)

3.17 ± 0.64

2.97 ± 0.71

2.96 ± 0.73

2.92 ± 0.78

3.17 ± 0.83

3.03 ± 0.94

Triglycerides (mmol/L)

1.58 ± 0.43

1.88 ± 0.49

1.48 ± 0.29

1.61 ± 0.43°°

1.68 ± 0.53

1.51 ± 0.67°°