Table 1.
Clinical characteristics over the course of the study
| Characteristic | Baseline (N=92) |
6 Months (N=90) |
12 Months (N=90) |
24 Months (N=92) |
AUC (N=92) |
|---|---|---|---|---|---|
| BMI (kg/m2) | 32.4 (3.6) | 29.7 (4.0)* | 29.9 (4.2)* | 31.1 (4.2)* | 30.3 (3.7) |
| Waist Circumference (cm) | 101.6 (11.0) | 95.0 (11.7)* | 96.0 (12.2)* | 98.1 (12.6)* | 96.4 (10.6) |
| Mean Arterial Pressure (mmHg) | 86.4 (7.6) | 83.3 (7.2)* | 84.1 (7.6)* | 85.7 (7.8) | 84.6 (5.4) |
| Pulse Pressure (mm Hg) | 40.0 (7.6) | 39.3 (7.6) | 37.0 (7.1)* | 37.8 (7.5)* | 38.6 (4.8) |
| Glucose (mg/dL) | 98.8 (9.2) | 98.2 (9.2) | 98.9 (8.8) | 98.1 (10.4) | 98.5 (6.1) |
| Insulin (µU/mL)† | 12.5 (10.1, 16.2) | 11.3 (9.1, 14.9)* | 12.0 (9.3, 16.0) | 12.1 (9.6, 16.2) | 11.4 (9.7, 14.3) |
| HOMA-IR (mmol/L × µU/mL)† | 3.0 (2.5, 4.2) | 2.8 (2.2, 3.6)* | 2.9 (2.2, 4.0) | 3.1 (2.2, 4.0) | 2.8 (2.4, 3.5) |
| LDL-C (mg/dL) | 124.9 (34.3) | 120.6 (33.4) | 124.5 (33.5) | 123.0 (33.7) | 123.0 (29.2) |
| HDL-C (mg/dL) | 51.3 (14.6) | 52.5 (13.8) | 54.3 (13.8)* | 54.0 (14.2)* | 53.4 (13.1) |
| Triglycerides (mg/dL)† | 110.5 (74, 189) | 89 (64, 138)* | 99.5 (73, 135)* | 98 (77, 146)* | 94.9 (73.0, 137.9) |
| CRP (mg/L)† | 2.5 (1.3, 5.2) | 1.9 (0.85, 3.8)* | 2.0 (0.80, 3.7)* | 2.5 (0.83, 4.5)* | 1.8 (0.76, 2.7) |
| Leptin (ng/mL) | 22.7 (13.0) | 15.0 (10.6)* | 19.1 (14.2)* | 20.7 (13.3)* | 17.7 (10.1) |
| Adiponectin (µg/mL) | 11.2 (5.9) | 11.7 (5.9) | 11.2 (5.7) | 9.6 (5.5)* | 11.0 (5.2) |
| Aldosterone (pg/mL)† | 97.1 (78.5, 126.5) | 107 (79.3, 147) | 102 (83.9, 140) | 108.5 (88, 160)* | 108.0 (97.4, 131.8) |
| Sodium Excretion (mmol/24hr)# | 187.3 (64.3) | 156.2 (66.3)* | 154.0 (61.2)* | 154.0 (61.6)* | 157.4 (27.3) |
| Heart Rate (beats/min) | 62.7 (8.2) | 60.7 (7.5)* | 62.6 (8.8) | 61.9 (8.3) | 62.0 (5.2) |
| Carotid-femoral PWV (cm/s)† | 817 (700, 934.5) | 767.5 (683, 907.5)* | 785.5 (680.3, 907.5)* | 787.3 (690.3, 903) | 774.6 (717.0, 875.0) |
| Brachial-ankle PWV (cm/s) | 1218.7 (128.4) | 1196.5 (140.8) | 1201.2 (130.9) | 1205.3 (130.5) | 1207.9 (108.2) |
| Femoral-ankle PWV (cm/s) | 946.1 (102.9) | 945.0 (112.9) | 939.8 (105.5) | 941.0 (100.6) | 945.3 (78.0) |
Mean (SD) or median (interquartile range (IQR)) are shown.
*
P<0.05 versus baseline in a linear mixed model with time since baseline as a nominal variable and with adjustment for intervention arm. LDL-C=low density lipoprotein cholesterol, HDL-C=high density lipoprotein cholesterol, HOMA-IR= homeostasis model assessment of insulin resistance, CRP=C-reactive protein, PWV=Pulse Wave Velocity, AUC=area under the curve divided by total follow-up time in years.
†
Log transformed for mixed modeling and AUC calculation; median and IQR AUC values shown were back transformed.
#
Baseline N=71, 6 Months N=68, 12 Months N=68, 24 Months N=60.