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Table 1 Primary baseline anthropometric, clinical, and biochemical features of the study groups

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 A° Arm B*° Arm C* Arm C°
Age, years (range) 11.7 (8.0–13.5) 11.7 (8.0–13.6) 12.0 (8.2–13.5) 11.8 (8.1–13.1) 11.8 (8.0–13.2)
N° and sex (male/female) 53 (27/26) 58 (29/29) 45 (23/22) 35 (19/16) 38 (21/17)
Tanner stage      
  Prepubertal, n (%) 30 (56.6) 33 (56.9) 24 (53.3) 19 (54.3) 21 (55.3)
  Pubertal, n (%) 23 (43.4) 25 (43.1) 21 (46.6) 16 (45.7) 17 (44.7)
  Prepubertal/pubertal ratio, n (%) 30/23 (56.6/43.4) 33/25 (56.9/43.1) 24/21 (53.3/46.6) 19/16 (54.3/45.7) 21/17 (55.3/44.7)
BMI, SDS 2.32 ± 0.53 2.33 ± 0.57 2.23 ± 0.57 2.27 ± 0.74 2.29 ± 0.77
Acanthosis nigricans, n (%) 7 (13.2) 8 (13.8)1 6 (13.3) 4 (11.4) 5 (13.1)2
  Prepubertal, n (%) 2 (3.8) 3 (5.2) 2 (4.4) 1 (2.8) 2 (5.3)
  Pubertal, n (%) 5 (9.4) 5 (8.6) 4 (8.9) 3 (8.6) 3 (7.9)
Waist circumference, SDS 4.0 ± 1.4 3.9 ± 1.5 3.8 ± 1.1 4.1 ± 1.3 4.0 ± 1.3
Hip circumference, SDS 3.2 ± 1.0 3.3 ± 1.1 3.1 ± 1.3 3.2 ± 1.2 3.3 ± 1.2
Systolic BP, mmHg 115.9 ± 8.7 116.5 ± 8.8 118.2 ± 8.7 120.1 ± 7.9 119.8 ± 8.0
Diastolic BP, mmHg 68.2 ± 8.9 69.5.2 ± 8.9 69.4 ± 9.3 69.4 ± 8.6 69.9 ± 8.7
Fasting glucose, mg/dL 90.62 ± 4.32 91.23 ± 4.39 89.63 ± 3.17 90.90 ± 5.71 90.12 ± 5.79
Fasting insulin, μU/mL 27.60 ± 7.83 27.48 ± 7.92 26.71 ± 9.36 27.39 ± 8.61 27.46 ± 8.55
HbA1c, %, mmol/mol 5.63 ± 0.54 5.66 ± 0.57 5.70 ± 0.52 5.68 ± 0.58 5.69 ± 0.59
HOMA-IR, mean (range) 5.69 (3.60–9.92) 5.76 (3.60–10.67) 5.68 (2.00–10.90) 5.78 (4.21–8.89) 5.76 (3.21–8.89)
  Prepubertal 5.61 (3.60–8.04) 5.72 (3.60–10.67) 4.72 (2.00–8.38) 5.32 (3.25–7.98) 5.32 (3.21–7.98)
  Pubertal 7.41 (4.67–9.92) 7.39 (4.67–9.92) 6.31 (3.82–10.90) 7.19 (4.38–8.89) 7.19 (4.38–8.89)
ISOGTT, SDS 1.40 ± 0.24 1.42 ± 0.26 1.42 ± 0.22 1.56 ± 0.48 1.58 ± 0.49
  Prepubertal 1.51 ± 0.15 1.52 ± 0.16 1.79 ± 0.55 1.56 ± 0.11 1.59 ± 0.15
  Pubertal 1.27 ± 0.27 1.29 ± 0.31 1.35 ± 0.55 1.30 ± 0.22 1.31 ± 0.23
Insulinogenic index, mean (range) 3.66 (1.90–9.25) 3.61 (1.70–9.25) 2.54 (1.91–10.2) 3.12 (1.15–9.70) 3.07 (1.13–9.70)
  Prepubertal 3.43 (2.29–9.25) 3.42 (2.29–9.25) 2.57 (1.29–10.26) 3.94 (2.51–9.70) 3.94 (2.51–9.70)
  Pubertal 2.98 (1.90–6.36) 2.95 (1.70–6.36) 1.75 (0.63–4.30) 2.25 (1.15–3.24) 2.25 (1.13–3.29)
Disposition index, mean (range) 4.42 (2.25–11.97) 4.48 (2.22–12.02) 4.01 (0.83–11.72) 3.79 (1.88–9.28) 3.84 (1.88–14.78)
  Prepubertal 5.52 (2.25–11.97) 5.55 (2.22–12.02) 4.59 (2.31–11.72) 5.68 (4.30–14.78) 5.69 (4.30–14.78)
  Pubertal 4.42 (2.99–6.76) 4.44 (2.73–6.76) 2.48 (0.83–5.67) 2.72 (1.99–3.79) 2.79 (1.88–6.39)
Glucose metabolism abnormalities, n (%) 8 (15.1) 9 (15.5) 6 (13.3) 4 (11.4) 5 (11.4)
IGT 6 (11.3) 7 (12.1)1 5 (11.1) 4 (11.4) 4 (10.5)
T2DM 2 (3.8) 2 (3.4) 1 (2.2) - 1 (2.6)2
  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; *per protocol analysis; °intention to treat analysis. 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.