Table 2.
Mean (SE) of Arterial, Hemodynamic and Neuroendocrine Stress Outcomes by Treatment Arm, Averaged Across Postrandomization Months 6 and 12
| Placebo (n = 69) | TE + IMP (n = 63) | P value | |
|---|---|---|---|
| Non-Stress Test Measures | |||
| Resting SBP (mmHg) | 110.6 (0.8) | 108.5 (0.8) | 0.05 |
| Resting DBP (mmHg) | 70.5 (0.6) | 68.8 (0.6) | 0.04 |
| BMI (kg/m2) | 25.6 (0.1) | 25.7 (0.1) | .56 |
| Waist circumference (cm) | 89.2 (0.5) | 89.3 (0.5) | 0.85 |
| LDL cholesterol (mg/dL) | 119.0 (1.7) | 107.9 (1.8) | <0.0001 |
| HDL cholesterol (mg/dL) | 68.2 (0.9) | 68.1 (0.9) | 0.95 |
| Fasting insulin (mIU/L) | 12.8 (0.5) | 11.4 (0.5) | 0.04 |
| Fasting glucose (mg/dL) | 89.8 (0.9) | 87.7 (0.9) | 0.11 |
| HOMA-IR (mass units) | 2.9 (0.1) | 2.4 (0.1) | 0.01 |
| Insulin resistance (HOMA ≥ 3.2) % | 13.6% | 8.8% | 0.23 |
| Fasting triglycerides (mg/dL) | 89.2 (3.5) | 88.6 (3.6) | 0.90 |
| FMD (%) | 6.4 (0.5) | 7.1 (0.5) | 0.29 |
| NMD (%) | 30.0 (0.9) | 30.0 (0.9) | 0.99 |
| Measures Obtained during Stress Testing (averaged across all testing phases) | |||
| SBP (mmHg) | 125.2 (0.8) | 126.4 (0.9) | 0.32a |
| DBP (mmHg) | 77.1 (0.5) | 76.4 (0.5) | 0.29 |
| Heart rate (bpm) | 75.3 (0.6) | 74.3 (0.7) | 0.30 |
| Cardiac output (l/min) | 6.9 (0.1) | 7.2 (0.1) | 0.06 |
| Total peripheral resistance (mmHg*min*mL-1) | 1198.2 (21.9) | 1102.3 (23.5) | 0.003 |
| Cortisol (μg/dL) | 7.3 (0.3) | 7.0 (0.3) | 0.40 |
| ACTH (pg/mL) | 61.1 (1.3) | 59.7 (1.3) | 0.45 |
| Epinephrine (pg/mL) | 48.6 (3.7) | 39.4 (3.6) | 0.06 |
| Norepinephrine (pg/mL) | 408.6 (12.0) | 393.3 (12.1) | 0.37 |
| IL-6 (pg/mL) | 1.36 (0.04) | 1.40 (0.04) | 0.50 |
| Baroreceptor reflex sensitivity (msec/mmHg) | 5.2 (0.2) | 5.7 (0.02) | 0.01 |
Abbreviations: ACTH, adenocorticotropic hormone; DBP, diastolic blood pressure; FMD, flow-mediated dilation; HDL, high-density lipoprotein; HOMA-IR, homeostatic model assessment of insulin resistance; IL-6, interleukin-6; LDL, low-density lipoprotein; NMD, nitroglycerine-mediated dilatation; SBP, systolic blood pressure.
aNote: As there were no significant treatment-by-phase interactions, only the P values examining the main effect of treatment, averaged across all phases, are provided.