Table 1.
Baseline Characteristics of Study Participants by Intervention Group
| Characteristics | Total | Placebo | Metformin | Lifestyle | |
|---|---|---|---|---|---|
| N | 3187 | 1060 | 1062 | 1065 | |
| Age at randomization | Median(IQR) | 49.9 (43.0, 57.6) | 49.6 (43.3, 57.4) | 50.4 (44.0, 57.3) | 49.6 (42.2, 58.3) |
| Sex | Male | 1029 (32%) | 329 (31%) | 360 (34%) | 340 (32%) |
| Female | 2158 (68%) | 731 (69%) | 702 (66 %) | 725 (68%) | |
| Race/ethnicity | White | 1746 (55%) | 575 (54%) | 597 (56%) | 574 (54%) |
| African American | 636 (20%) | 217 (20%) | 218 (21%) | 201 (19%) | |
| Hispanic | 498 (16%) | 164 (15%) | 160 (15%) | 174 (16%) | |
| American Indian | 165 (5%) | 55 (5%) | 51(5%) | 59 (6%) | |
| Asian | 142 (5%) | 49 (5%) | 36 (3%) | 57 (5%) | |
| Income# | <50,000 | 1622 (55%) | 553 (57%) | 517 (53%) | 552 (56%) |
| 50,000+ | 1312 (45%) | 419 (43%) | 460 (47%) | 433 (44%) | |
| Marital Status | Living together/Married | 2099 (66%) | 707 (67%) | 688 (65%) | 704 (66%) |
| Others | 1088 (34%) | 353 (33%) | 374 (35%) | 361 (34%) | |
| Education Level | 12 yrs or less | 822 (26%) | 280 (26%) | 267 (25%) | 275 (26%) |
| 13–16 yrs | 1534 (48%) | 511 (48%) | 508 (48%) | 515 (48%) | |
| 17+ yrs | 831 (26%) | 269 (25%) | 287 (27%) | 275 (26%) | |
| Leisure activity(met-hours) | Median(IQR) | 9.9 (3.9, 20.7) | 10.0 (4.0, 21.2) | 10.0 (4.0, 20.8) | 9.5 (3.9, 19.6) |
| BMI (kg/m2) | Median(IQR) | 32.8 (29.0, 37.4) | 33.2 (28.9, 37.8) | 32.7 (29.1, 37.3) | 32.6 (28.9, 37.2) |
| BDI score | Median(IQR) | 3.0 (1.0, 7.0) | 3.0 (1.0, 7.0) | 3.0 (1.0, 7.0) | 3.0 (1.0, 7.0) |
| BDI>=11 | Yes | 328 (10%) | 115 (11%) | 104 (10%) | 109 (10%) |
| No | 2859 (90%) | 945 (89%) | 958 (90%) | 956 (90%) | |
| Taking Antidepressant | Yes | 181 (6%) | 53 (5%) | 70 (7%) | 58 (5%) |
| No | 3006 (94%) | 1007 (95%) | 992 (93%) | 1007 (95%) | |
| Antidepressant Class | |||||
| SSRI | 141 (78%) | 41 (77%) | 55 (79%) | 45 (78%) | |
| Tricyclics | 40 (22%) | 12 (23%) | 15 (21%) | 13 (22%) | |
| CRP (mg/dl) | Median(IQR) | 0.37 (0.17–0.76) | 0.38 (0.17, 0.78) | 0.35 (0.17, 0.73) | 0.38 (0.17, 0.76) |
| IL6 (pg/ml) | Median(IQR) | 1.93 (1.28–2.96) | 1.95 (1.31, 2.97) | 1.87 (1.25, 2.95) | 1.95 (1.29, 2.98) |
Data presented as mean (SD) or %.
P -values are based on χ2 tests for categorical variables and Kruskal-Wallis test for continuous variables. BMI = Body Mass Index; BDI = Beck Depression Inventory total score; CRP = C-reactive protein; and IL6= Interleukin 6.