Clinical Study

The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial

Table 1

Baseline characteristics of patients treated with off label metformin and treated with metformin in a randomized clinical trial.

Daily clinical practice group
()
RCT group
()
value
chi2
value
Mann-Whitney

Gender
 (i) Boys11 (57.9)6 (26.1)0.037
 (ii) Girls8 (42.1)17 (73.9)
Age (years)14.3 (11.7–15.7)13.6 (12.6–15.3)0.99
Ethnicity
 (i) Caucasian11 (57.9)23 (100)NA
 (ii) Other8 (42.1)0 (0)
Height (cm)168.3 (161.5–177.2)162.9 (159.9–168.0)0.08
Weight (kg)92.5 (75.2–104.0)82.2 (75.4–92.7)0.16
BMI (kg/m2)31.3 (28.8–33.8)29.8 (28.1–34.5)0.66
BMI-SDS3.23 (3.05–3.64)3.10 (2.72–3.52)0.37
 BMI-SDS ≥ 3.015 (78.9)13 (56.5)0.13
Tanner stage
 (i) Prepubertal (TS1)3 (15.8)3 (13.0)0.42
 (ii) Pubertal (TS2–4)5 (26.4)17 (74.0)
 (iii) Postpubertal (TS5)1 (5.6)3 (13.0)
 (iv) Unknown10 (52.6)0 (0)
FPG (mmol/l)5.0 (4.8–5.6)4.8 (4.7–5.0)0.015
 FPG ≥ 5.6 mmol/l5 (26.3)0 (0)NA
FPI (μU/ml)31.0 (22.0–41.9)18.0 (11.0–27.0)0.005
 FPI > 15 μU/ml17 (89.5)14 (60.9)0.036
HOMA-IR7.74 (4.48–8.96)4.00 (2.30–6.36)0.003
 HOMA-IR ≥ 3.417 (89.5)10 (43.5)0.019
HbA1c (mmol/mol)36 (32–39)33 (31–34)0.052

Data are presented as median (interquartile range) or (%). .
RCT: randomized clinical trial; BMI ( SDS): body mass index (standard deviation score); FPG: fasted plasma glucose; FPI: fasted plasma insulin; HOMA-IR: homeostasis model assessment for insulin resistance; NA: not applicable.