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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)

From: Policaptil Gel Retard® significantly reduces body mass index and hyperinsulinism and may decrease the risk of type 2 diabetes mellitus (T2DM) in obese children and adolescents with family history of obesity and T2DM

  Arm A Arm B Arm C
  T 0 T 1 T 0 T 1 T 0 T 1
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)°°
ISOGTT, 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°°
  1. BMI, body mass index; BP, blood pressure; HOMA-IR, homeostasis model of assessment for insulin-resistance; ISOGTT, Matsuda index; SDS, standard deviation score; IGT, impaired glucose tolerance; T2DM, type 2 diabetes mellitus. 1patient with acanthosis nigricans and IGT dropped out in the per protocol analysis for non-compliance: 2patient with acanthosis nigricans and T2DM dropped out in the per protocol analysis for non-compliance. Cross-sectional study: Arm A vs. Arm B or Arm A vs.Arm C: ##p < 0.005. Longitudinal study: Arm A vs. Arm A. Arm B vs. Arm B, Arm C vs. Arm C: *p < 0.05, **p < 0.005, ***p < 0.0005; Arm A vs. Arm B or Arm A vs. Arm C: °p < 0.05, °°p < 0.005, °°°p < 0.0005; Arm B vs. Arm C: §§p < 0.005, §§§ p < 0.0005.