Table 1.
Baseline Characteristics Overall and by Randomization Arm
| Characteristics | Overall | DSE | ILI | P-Value |
|---|---|---|---|---|
| Number of Subjects | 5145 (100) | 2575 (50.05) | 2570 (49.95) | |
| Age (Years) | 58.75 ± 0.1 | 58.9 ± 0.14 | 58.59 ± 0.13 | 0.1 |
| Gender | . | . | . | 0.82 |
| Male | 2082 (40.47) | 1038 (40.31) | 1044 (40.62) | |
| Female | 3063 (59.53) | 1537 (59.69) | 1526 (59.38) | |
| Race/Ethnicity | . | . | . | 0.98 |
| African American | 804 (15.63) | 404 (15.69) | 400 (15.57) | |
| Caucasian | 3252 (63.22) | 1631 (63.34) | 1621 (63.1) | |
| Hispanic | 680 (13.22) | 340 (13.2) | 340 (13.23) | |
| Other | 408 (7.93) | 200 (7.77) | 208 (8.1) | |
| Body weight (kg) | 100.71 ± 0.27 | 100.85 ± 0.37 | 100.56 ± 0.39 | 0.59 |
| Body Mass Index (kg/m^2) | 35.94 ± 0.08 | 36 ± 0.11 | 35.89 ± 0.12 | 0.51 |
| Smoking Status | . | . | . | 0.71 |
| Never | 2576 (50.18) | 1302 (50.7) | 1274 (49.65) | |
| Former | 2331 (45.4) | 1156 (45.02) | 1175 (45.79) | |
| Current | 227 (4.42) | 110 (4.28) | 117 (4.56) | |
| Alcohol Consumption | . | . | . | 0.6 |
| No drinks/week | 3478 (67.82) | 1736 (67.63) | 1742 (68.02) | |
| 1–3 drinks/week | 994 (19.38) | 491 (19.13) | 503 (19.64) | |
| 4+ drinks/week | 656 (12.79) | 340 (13.25) | 316 (12.34) | |
| Physical Activity | . | . | . | |
| Maximal MET value | 7.19 ± 0.03 | 7.18 ± 0.04 | 7.2 ± 0.04 | 0.67 |
| Self-Reported Duration of Diabetes | 5 (2, 10) | 5 (2, 10) | 5 (2, 10) | 0.16 |
| Medications | . | . | . | |
| Bone Positive | 1308 (25.42) | 649 (25.2) | 659 (25.64) | 0.72 |
| Bone Negative | 2378 (46.22) | 1199 (46.56) | 1179 (45.88) | 0.62 |
| Steroids | 6 (0.12) | 2 (0.08) | 4 (0.16) | 0.45 |
| Bisphosphonates | 95 (1.85) | 43 (1.67) | 52 (2.02) | 0.35 |
| TZDs | 1337 (25.99) | 689 (26.76) | 648 (25.21) | 0.21 |
| Insulin Use (from any source) | 980 (19.05) | 500 (19.42) | 480 (18.68) | 0.5 |
| Beck Depression Score | 4 (2, 8) | 4 (2, 8) | 4 (2, 8) | 0.68 |
| eGFR | 94.03 ± 0.32 | 93.68 ± 0.44 | 94.38 ± 0.46 | 0.27 |
| HbA1c | 7.28 ± 0.02 | 7.31 ± 0.02 | 7.25 ± 0.02 | 0.06 |
eGFR = estimated glomerular filtration rate, HbA1c = Hemoglobin A1c. N (%) or Mean ± Standard Error or Median (Q1, Q3). Chi-Square and Students T-test were used, with the exception of Self-Reported Diabetes Duration, the Beck Depression Score which used the Wilcoxon Rank Sum and Steroids which used a Fisher’s Exact Test