Table 3. Clinical variables from baseline to 12 months (mean ±s.d.).

Variable	Baseline		3 Months		6 Months		9 Months		12 Months		P-valuesa
	Control (n=54)	Comparator (n=58)	Control (n=52)	Comparator (n=55)	Control (n=50)	Comparator (n=47)	Control (n=43)	Comparator (n=46)	Control (n=46)	Comparator (n=47)	Time	Group	Interaction
Males/females	11/43	17/41	11/41	16/39	9/41	14/33	8/35	13/33	10/36	13/47
Glucose (mmol/l)	5.23±0.53	5.31±0.50	5.10±0.39	5.17±0.42	5.20±0.38	5.23±0.46	5.15±0.40	5.08±0.45	5.17±0.36	5.20±0.37	0.001	0.747	0.652
Insulin (m/Ul)b	11.35 (8.33–15.10)	10.70 (7.45–13.65)	9.40 (6.83–12.28)	8.30 (6.30–10.70)	9.75 (6.50–12.25)	8.60 (6.30–10.50)	8.40 (6.80–13.10)	7.75 (5.98–10.70)	8.80 (6.15–11.90)	8.50 (6.10–10.90)	<0.001c	0.093c	0.675c
Tot Chol (mmol/l)	5.21±0.88	5.20±0.88	5.01±0.83	5.08±0.79	5.22±0.74	5.26±0.77	5.20±0.81	5.13±0.74	5.22±0.98	5.20±0.80	0.202	0.914	0.778
Trigs (mmol/l)b	1.24 (0.80–1.59)	1.02 (0.75–1.45)	1.01 (0.77–1.40)	1.07 (0.82–1.30)	0.95 (0.81–1.36)	0.99 (0.79–1.31)	0.92 (0.75–1.53)	0.90 (0.73–1.26)	0.97 (0.75–1.46)	0.94 (0.71–1.17)	<0.001d	0.469d	0.749d
HDL (mmol/l)b	1.34 (1.14–1.67)	1.40 (1.16–1.62)	1.38 (1.18–1.55)	1.29 (1.17–1.52)	1.56 (1.32–1.73)	1.40 (1.25–1.64)	1.56 (1.36–1.73)	1.51 (1.29–1.70)	1.51 (1.36–1.70)	1.46 (1.26–1.72)	<0.001c	0.429c	0.373c
LDL (mmol/l)	3.19±0.80	3.25±0.82	3.10±0.74	3.20±0.71	3.13±0.69	3.29±0.67	3.12±0.73	3.14±0.68	3.14±0.84	3.20±0.71	0.163	0.533	0.702
Tot Chol: HDL	3.90±1.16	3.89±1.28	3.79±1.03	3.90±0.90	3.51±0.88	3.74±0.85	3.43±0.81	3.52±0.96	3.46±0.90	3.56±0.92	<0.001	0.563	0.671
Isoprostanes (pg/ml)	181.48±62.54	175.71±59.51	158.50±52.59	141.25±47.47					214.21±77.75	198.95±64.09	<0.001	0.159	0.628

Abbreviations: HDL, high-density lipoprotein; IQR, interquartile range; LDL, low-density lipoprotein; Tot Chol, total cholesterol; Trigs, triglycerides.

^aLinear mixed model, significant at P<0.05.

^bMedian (IQR).

^cLog transformed.

^dSquare root transformed.