Table 1.
Baseline Characteristics by Number of Metabolic Syndrome Criteria Met
| No Metabolic Syndrome (2 or fewer criteria) (N=636) |
3 Criteria (N=349) |
4 Criteria (N=1094) |
5 Criteria (N=1298) |
P-value(1) | P-value(2) | ||
|---|---|---|---|---|---|---|---|
| Randomized Treatment Assignment | Monotherapy | 335 (52.7%) | 183 (52.4%) | 524 (47.9%) | 633 (48.8%) | 0.085 | 0.334 |
| Combination Therapy | 301 (47.3%) | 166 (47.6%) | 570 (52.1%) | 665 (51.2%) | |||
| Demographics, baseline physical exam and laboratory measures: | |||||||
| Age | N | 636 | 349 | 1094 | 1298 | 0.052 | <.001* |
| Mean (Std Dev) | 63.1 (9.2) | 62.6 (9.3) | 63.4 (8.6) | 64.5 (8.4) | |||
| Gender | Female | 75 (11.8%) | 46 (13.2%) | 152 (13.9%) | 230 (17.7%) | 0.015* | 0.015* |
| Male | 561 (88.2%) | 303 (86.8%) | 942 (86.1%) | 1068 (82.3%) | |||
| Race | American Indian/Alaska Native/Aboriginal Canadian | 1 (0.2%) | 1 (0.3%) | 4 (0.4%) | 15 (1.2%) | 0.186 | 0.002* |
| Asian | 9 (1.4%) | 10 (2.9%) | 15 (1.4%) | 6 (0.5%) | |||
| Black/African American | 21 (3.3%) | 6 (1.7%) | 40 (3.7%) | 49 (3.8%) | |||
| Native Hawaiian or Other Pacific Islander | 4 (0.6%) | 1 (0.3%) | 1 (0.1%) | 6 (0.5%) | |||
| White | 593 (93.2%) | 323 (92.6%) | 1008 (92.1%) | 1192 (91.8%) | |||
| Muti-racial or Other | 8 (1.3%) | 8 (2.3%) | 25 (2.3%) | 30 (2.3%) | |||
| Ethnicity | Not Hispanic or Latino | 621 (97.6%) | 339 (97.1%) | 1053 (96.3%) | 1224 (94.3%) | 0.013* | 0.025* |
| Hispanic or Latino | 15 (2.4%) | 10 (2.9%) | 41 (3.7%) | 73 (5.6%) | |||
| Systolic blood pressure (mmHg) | N | 636 | 349 | 1093 | 1297 | <.001* | <.001* |
| Mean (Std Dev) | 121.7 (15.1) | 128.1 (15.4) | 128.6 (16.1) | 131.1 (16.4) | |||
| Median (25th, 75th%-tile) | 120.0 (110.0, 129.0) | 128.0 (117.0, 138.0) | 128.0 (118.0, 139.0) | 130.0 (120.0, 141.0) | |||
| Diastolic blood pressure (mmHg) | N | 636 | 349 | 1093 | 1297 | <.001* | 0.224 |
| Mean (Std Dev) | 71.8 (9.5) | 75.7 (9.4) | 75.0 (9.4) | 74.7 (10.1) | |||
| Median (25th, 75th%-tile) | 71.0 (67.0, 78.0) | 76.0 (70.0, 82.0) | 74.0 (70.0, 80.0) | 75.0 (68.0, 80.0) | |||
| Body Mass Index (kg/m2) | N | 635 | 349 | 1091 | 1297 | <.001* | <.001* |
| Mean (Std Dev) | 27.8 (3.9) | 28.7 (4.6) | 31.2 (5.1) | 33.6 (5.1) | |||
| Median (25th, 75th%-tile) | 27.0 (25.0, 30.0) | 28.0 (26.0, 30.0) | 30.0 (28.0, 34.0) | 33.0 (30.0, 36.0) | |||
| Waist circumference (inches) | N | 630 | 348 | 1093 | 1296 | <.001* | <.001* |
| Mean (Std Dev) | 38.1 (4.1) | 39.7 (4.4) | 42.4 (4.9) | 45.1 (4.6) | |||
| Median (25th, 75th%-tile) | 38.0 (35.8, 40.0) | 39.0 (37.0, 42.0) | 42.0 (39.0, 45.7) | 44.1 (42.0, 48.0) | |||
| Glucose (mg/dL) | N | 636 | 346 | 1094 | 1298 | <.001* | <.001* |
| Mean (Std Dev) | 96.9 (10.5) | 99.0 (16.4) | 110.3 (21.9) | 120.9 (23.7) | |||
| Median (25th, 75th%-tile) | 97.0 (91.0, 103.0) | 96.0 (91.0, 99.0) | 104.5 (95.0, 123.0) | 116.0 (105.0, 134.0) | |||
| Insulin (mg/dL) | N | 635 | 348 | 1090 | 1294 | <.001* | <.001* |
| Mean (Std Dev) | 13.3 (13.4) | 14.7 (11.3) | 18.8 (18.4) | 26.1 (35.0) | |||
| Median (25th, 75th%-tile) | 10.2 (7.0, 15.6) | 12.6 (7.9, 18.5) | 14.4 (9.3, 22.5) | 18.3 (12.2, 28.6) | |||
| HOMA1-IR | N | 635 | 345 | 1090 | 1294 | <.001* | <.001* |
| Mean (Std Dev) | 3.2 (3.3) | 3.6 (2.9) | 5.2 (5.5) | 7.9 (11.1) | |||
| Median (25th, 75th%-tile) | 2.4 (1.7, 3.8) | 2.9 (1.9, 4.5) | 3.8 (2.4, 6.0) | 5.4 (3.4, 8.5) | |||
| History of diabetes | 64 (10.1%) | 27 (7.7%) | 320 (29.3%) | 744 (57.3%) | <.001* | <.001* | |
(1)
Comparison between no metabolic syndrome and any number of criteria
(2)
Comparison among 3, 4, or 5 criteria met