Table 2

Summary of vascular and metabolic variables by sequence and period

Variable (mean±SD)	Sequence AB (pioglitazone/placebo) N=39				Sequence BA (placebo/pioglitazone) N=41				Treatment effect*
	Period 1 (pioglitazone)		Period 2 (placebo)		Period 1 (placebo)		Period 2 (pioglitazone)		Treatment effect*
	Baseline	Change	Baseline	Change	Baseline	Change	Baseline	Change	Estimate (95% CI)	P value
CAVI average	7.38±1.23	−0.37±0.90	7.21±1.25	−0.07±0.66	7.26±1.01	0.11±0.65	7.34±0.92	−0.27±0.56	−0.32 (-0.54, - 0.10)	0.005
Log-transformed RHI	0.72±0.37	0.07±0.35	0.71±0.29	0.02±0.36	0.65±0.36	0.02±0.48	0.64±0.54	−0.05±0.35	−0.007 (-0.123 0.110)	0.91
PWV m/s	6.59±1.82	−0.31±2.06	7.15±1.22	−0.25±0.94	6.73±1.52	0.03±2.03	7.01±2.44	−0.31±1.86	−0.18 (-0.57,0.21)	0.37
Augmentation Index	23.59±16.33	−2.25±11.84	26.28±15.90	−1.75±10.01	26.24±10.9	−0.43±10.32	23.61±9.64	0.47±12.33	−1.36 (-4.11, 1.39)	0.33
Aortic Arch TBR*†	1.47±0.16	0.09±0.12			1.53±0.19	−0.05±0.27			0.01 (-0.16, 0.18)	0.84
Global TBR*†	1.68±0.14	0.03±0.20			1.66±0.19	0.04±0.30			0.09 (-0.04, 0.23)	0.17
Cholesterol	174.97±30.04	0.06±14.74	177.42±31.48	−2.44±15.83	169.71±30.18	1.35±21.73	171.58±36.69	−0.44±21.39	0.38 (-5.17, 5.92)	0.89
LDL mg/dL	90.9±29.38	0.14±14	93.58±28.43	−0.47±13.05	88.29±26.53	−0.88±18.64	93.32±31.95	−6.19±24.33	−1.65 (-6.38,3.09)	0.91
Triglycerides mg/dL	101.67±40.52	−20.94±39.57	97.19±44.85	−2.72±36.24	110.35±52.1	6.54±47.97	109.97±67.84	−14.47±45.33	−18.09 (-30.52, -5.67)	0.005
HDL mg/dL	63.79±20.37	4.14±12.29	64.33±18.29	−1.36±7.91	59±20.91	1.28±10.42	59.34±22.93	5.42±11.53	4.72 (1.27, 8.18)	0.008
HDL particle no mcmol/L	31.2±6.6	−1.58±3.83	31.13±7.41	0.18±2.62	31.36±6.51	0.11±3.45	31.61±6.65	−1.76±4.23	−1.84 (-2.90,- 0.78)	0.0009
HDL size nm	9.79±0.66	0.27±0.42	9.84±0.63	−0.04±0.27	9.58±0.63	0.02±0.35	9.6±0.65	0.29±0.37	0.28 (0.18, 0.39)	<0.0001
LDL particle no nmol/L	958.1±396.6	−83.4±234.1	977.3±401.5	17.4±192.2	1037.5±387.4	−7.9±201.6	1032.1±411.5	−140.6±268.6	−117.1 (-183.3, -51.0)	0.0006
LDL size nm	20.86±0.52	0.49±0.66	21.14±0.57	−0.15±0.42	20.85±0.68	−0.11±0.48	20.87±0.63	0.43±0.74	0.51 (0.38, 0.71)	<0.0001
Cholesterol efflux value	0.92±0.17	0.03±0.16	0.88±0.19	0.04±0.18	0.88±0.19	0.01±0.17	0.89±0.2	0.07±0.16	0.03 (-0.02, 0.08)	0.28
Glucose mg/dL	89.74±14.74	−3.69±16.08	89.92±10.26	−1.72±6.44	88.66±9.07	−0.65±6.85	88.92±9.99	−3.17±9.15	−1.91 (-4.39, 0.58)	0.13
Insulin Pmol/L	17.26±10.66	−4.02±9.9	18.98±19.26	−2.85±9.02	17.63±11.71	1.18±6.21	17.74±10.19	−5.46±8.59	−3.77 (-6.22,- 1.31)	0.0031
Homa2-IR	2.18±1.34	−0.51±1.28	2.36±2.15	−0.33±0.98	2.22±1.41	0.14±0.73	2.24±1.25	−0.69±1.08	−0.23 (-0.35,- 0.11)	0.0003

Data are mean±SD. Change is defined as the post baseline value minus the baseline value during the period: that is, M3 – D1 for period 1, M8 – M5 for period 2.
*Linear mixed effects models were used to calculate the estimated treatment effect (the treatment group difference in the change score between pioglitazone and the placebo), its 95% CI and the p value.
†These measures are based on 18F-FDG/PET CT scans. For these two variables measured in period 1 only, the treatment effect and the p value are calculated based on analysis of covariance.
CAVI, Cardio-Ankle Vascular Index; ¹⁸F-FDG/PET CT scan, 18fluoro-D-glucose positron emission tomography integrated with CT; HDL, high-density lipoprotein; HOMA2IR, Homoeostasis Model Assessment of Insulin Resistance; LDL, low-density lipoprotein; PWV, pulse wave velocity; RHI, Reactive Hyperaemia Index; TBR, target/background ratio.