Table 2.

Trial outcomes

End Pointa	Treatment	Baseline	12 mo	Treatment Difference Between Groupsf
EF (%)	Control	58.7±8.5	57.6±8.5	1.5 (−4.3 to 7.3)
	Intervention	57.4±15.3	61.0±18.4
LV mass (g)	Control	140.3±48.7	141.3±48.7	−15.6 (−29.4 to −1.9)
	Intervention	157.9±50.5	145.6±50.5
LV mass indexed to BSA (g/m2)	Control	72.4±21.7	73.5±31.7	−8.1 (−15.5 to −0.8)
	Intervention	80.7±17.8	75.0±26.5
Global peak systolic strain (%)b	Control	−16.3±3.7	−13.0±6.9	−3.3 (−6.5 to −0.2)
	Intervention	−15.9±4.6	−15.9±7.6
Global peak systolic strain rate (s−1)c	Control	−0.97±0.2	−0.87±0.21	−0.2 (−0.3 to −0.08)
	Intervention	−1.02±0.3	−1.03±0.25
Global peak diastolic strain rate (s−1)d	Control	1.05±0.3	0.90±0.42	0.18 (0.02 to 0.34)
	Intervention	1.12±0.4	1.00±0.41
LV end-diastolic volume (ml)	Control	150.3±37	156.1±37	−23.8 (−44.7 to −2.9)
	Intervention	162.9±39.8	144.5±39.8
LV end-diastolic volume indexed to BSA (ml/m2)	Control	78.8±21.2	75.6±31.2	−12.4 (−23.2 to −1.5)
	Intervention	83.5±27	73.3±29.1
Aortic distensibility (mmHg−1×10−3)e	Control	4.4±2.6	2.1±2.6	1.8 (0.1 to 3.6)
	Intervention	3.4±2.5	3.1±2.5

EF, left ventricular ejection fraction; LV, left ventricle; BSA, body surface area.

^aMean±SD of observed values were adjusted using a linear mixed-effects model for study center, age, sex, and diabetes status.

^bSystolic strain values are conventionally expressed on a negative scale as a percentage change in LV length from baseline, with more negative changes denoting better systolic function.

^cSystolic strain rate values are expressed on a negative scale, with more negative changes denoting better systolic function.

^dDiastolic strain rate values are a measure of diastolic function, with greater values denoting better function.

^eAortic distensibility data were skewed and therefore logarithmically transformed values were used, with coefficients back-transformed for presentation.

^fTreatment effects are expressed as mean (95% CI) and were determined by the interaction of treatment group with time.