Table 1.
Baseline characteristics of patients treated with off label metformin and treated with metformin in a randomized clinical trial.
| Daily clinical practice group (n = 19) |
RCT group (n = 23) |
p value chi2 |
p value Mann-Whitney |
|
|---|---|---|---|---|
| Gender | ||||
| (i) Boys | 11 (57.9) | 6 (26.1) | 0.037 | |
| (ii) Girls | 8 (42.1) | 17 (73.9) | ||
| Age (years) | 14.3 (11.7–15.7) | 13.6 (12.6–15.3) | 0.99 | |
| Ethnicity | ||||
| (i) Caucasian | 11 (57.9) | 23 (100) | NA | |
| (ii) Other | 8 (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-SDS | 3.23 (3.05–3.64) | 3.10 (2.72–3.52) | 0.37 | |
| BMI-SDS ≥ 3.0 | 15 (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) Unknown | 10 (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/l | 5 (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/ml | 17 (89.5) | 14 (60.9) | 0.036 | |
| HOMA-IR | 7.74 (4.48–8.96) | 4.00 (2.30–6.36) | 0.003 | |
| HOMA-IR ≥ 3.4 | 17 (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 n(%). #n = 14.
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.