Table 3.
Secondary outcomes
|
Placebo group |
Metformin group |
Adjusted mean difference or ratio (95% CI) | p value | |||
|---|---|---|---|---|---|---|
| Mean (SD) | N | Mean (SD) | N | |||
| Maternal biochemistry at 36 weeks' gestation | ||||||
| Fasting glucose (mmol/L) | 4·42 (0·48) | 151 | 4·35 (0·45) | 143 | −0·060 (−0·163 to 0·043) | 0·25 |
| 2 h glucose (mmol/L)* | 5·96 (1·46) | 148 | 5·70 (1·32) | 142 | −0·251 (−0·565 to 0·062) | 0·12 |
| Fasting insulin (pmol/L) | 208·98 (91·12) | 131 | 227·73 (170·50) | 127 | 1·005 (0·901 to 1·120) | 0·93 |
| HOMA-IR score† | 5·98 (2·89) | 131 | 6·30 (4·78) | 123 | 0·974 (0·865 to 1·097) | 0·67 |
| C-reactive protein (mg/L) | 9·20 (7·10) | 150 | 7·47 (4·62) | 140 | 0·860 (0·743 to 0·996) | 0·04 |
| Cholesterol (mmol/L) | 6·32 (1·44) | 144 | 6·33 (1·74) | 139 | 1·004 (0·954 to 1·056) | 0·88 |
| HDL (mmol/L) | 1·70 (0·38) | 145 | 1·76 (0·43) | 138 | 0·051 (−0·040 to 0·142) | 0·27 |
| LDL (mmol/L) | 3·57 (1·13) | 126 | 3·77 (1·25) | 118 | 1·064 (0·982 to 1·152) | 0·13 |
| Triglycerides (mmol/L) | 2·79 (0·84) | 146 | 2·76 (0·88) | 140 | 0·993 (0·926 to 1·064) | 0·83 |
| Interleukin-6 (mmol/L) | 3·86 (4·10) | 131 | 2·93 (1·37) | 127 | 0·847 (0·754 to 0·952) | 0·01 |
| Leptin (ng/mL) | 105·0 (52·4) | 131 | 106·6 (58·8) | 127 | 1·005 (0·902 to 1·120) | 0·93 |
| Serum cortisol (nmol/L) | 821·7 (232·9) | 131 | 867·0 (225·5) | 127 | 1·062 (0·999 to 1·128) | 0·05 |
| NEFA (mmol/L) | 0·47 (0·18) | 131 | 0·46 (0·19) | 127 | 0·947 (0·859 to 1·044) | 0·27 |
| PAI-1 to PAI-2 ratio | 3·20 (2·61) | 131 | 2·97 (2·79) | 128 | 0·913 (0·771 to 1·081) | 0·29 |
| Cord-blood biochemical outcomes | ||||||
| Glucose (mmol/L) | 3·89 (1·24) | 79 | 4·06 (1·08) | 74 | 1·067 (0·974 to 1·170) | 0·16 |
| Insulin (pmol/L) | 76·05 (52·02) | 47 | 79·24 (61·12) | 57 | 1·060 (0·767 to 1·463) | 0·72 |
| HOMA-IR score† | 1·92 (1·39) | 38 | 1·91 (2·00) | 41 | 1·012 (0·701 to 1·462) | 0·95 |
| C-reactive protein (mg/L)‡ | 4·32 (19·55) | 78 | 2·36 (2·29) | 73 | .. | 0·74 |
| Anthropometric variables | ||||||
| Maternal weight gain during pregnancy (kg) | 7·23 (4·91) | 156 | 6·70 (6·00) | 143 | −0·680 (−1·863 to 0·503) | 0·26 |
| Ponderal index (mass [g]/height3 [cm])§ | 2·60 (0·41) | 143 | 2·67 (0·50) | 130 | 1·032 (0·996 to 1·069) | 0·08 |
All variables, except for maternal glucose and HDL, and neonatal C-reactive protein, were log-transformed for the statistical analysis and converted back to original scale for this table. HOMA-IR=homeostatic model assessment of insulin resistance. NEFA=non-esterified fatty acids. PAI=plasminogen activator inhibitor.
*
After a 75 g oral glucose challenge.
†
Fasting glucose (mmol/L) x insulin (μIU/L)/22·5.
‡
Kruskal–Wallis non-parametric test used.
§
Livebirths only; we removed outliers outside SD 6 and log-transformed data for the statistical analysis; results were back-transformed for this table.