Table 2.

Metabolic parameters, change over time and between the two randomization groups over time (OBS vs PTX).

Variable	OBS/PTX	OBS					PTX					OBS vs PTX	Power 80%***
	n	Baseline	±s.d. (25%; 75%)	5 years	±s.d. (25%; 75%)	P 0 vs 5 years	Baseline	±s.d. (25%; 75%)	5 years	±s.d. (25%; 75%)	P 0 vs 5 years	P**	OBS vs PTX over time***
Glucose (mmol/L)	37/43	5.1	(4.8; 5.9)	5.4	(5.1; 5.9)	0.238	5.2	(4.9, 5.9)	5.4	(4.9; 5.9)	0.967	0.336	0.35
Insulin (pmol/L)	37/43	70	(46; 130)	70	(45; 113)	0.504	71	(55; 129)	72	(51; 129)	0.790	0.780	27
Fasting glucose ≥7 mmol/L (n)	7/5	4		6			5		3				n.d.
HOMA-β	30/30*	101	(73; 125)	99	(73; 125)	0.975	111	(89; 140)	111	(89; 140)	0.811	0.858	n.d.
HOMA-IR	30/30*	1.07	(0.75; 1.52)	1.18	(0.75; 1.52)	0.688	1.32	(1.01; 2.23)	1.32	(1.01; 2.23)	0.388	0.921	n.d.
Apo A-1 (g/L)	37/43	1.9	(±0.3)	1.9	(±0.3)	0.201	1.9	(±0.3)	1.9	(±0.3)	0.637	0.530	0.13
Apo B (g/L)	37/43	1.1	(±0.3)	1	(±0.2)	0.007	1.1	(±0.3)	1.1	(±0,3)	0.935	0.064	0.12
BMI (kg/m²)	49/47	26.4	(23.4; 30.0)	26.7	(23.3; 29.9)	0.124	25.9	(24.4; 29.2)	27.3	(24.9; 29.2)	0.074	0.673	0.82
Weight (kg)	50/53	75.1	(±12.2)	75.9	(±14.5)	0.274	75.2	(±11.1)	75.5	(±11.1)	0.660	0.787	2.07
DXA
Total FM (kg)	50/53	29.2	(±9.2)	30.1	(±9.7)	0.136	28.3	(±8.8)	28.7	(±8.6)	0.562	0.462	2.17
Total LM (kg)	50/53	41.5	(37.4; 47.1)	42.3	(36.8; 48.4)	0.508	42.4	(40.1; 46.4)	43.0	(39.6; 46.8)	0.905	0.639	1.33
Trunk fat (kg)	44/46	14.8	(±5.4)	15.7	(±6.3)	0.025	14.5	(±4.3)	14.8	(±4.7)	0.469	0.228	1.55

P-Values: bold: <0.05; italic: non-parametric test; normal: parametric test.

*Patients with glucose ≥7.0 mmol/L at visit 0 or 5 were excluded listwise; **difference between groups for change over time; ***difference between groups that could have been detected with 80% power as measure for potential type 2 error.