Table 1.
Demographic and clinical characteristics at the start of the enrichment phase according to tertiles of Insulin Resistance
| Characteristics | Tertile 1 (n = 366) | Tertile 2 (n = 369) | Tertile 3 (n = 367) | p-value for trend |
|---|---|---|---|---|
| HOMA-IR | 2.3 [0.0-3.9] | 5.9 [3.9–10.3] | 19.6 [10.4–286.0] | NA |
| Age, years | 63.1 (9.4) | 64.4 (8.6) | 63.6 (8.2) | 0.445 |
| Sex, n (%) | ||||
| Women | 72 (19.7%) | 114 (30.9%) | 99 (27.0%) | 0.002 |
| Men | 294 (80.3%) | 255 (69.1%) | 268 (73.0%) | |
| Race, n (%) | ||||
| Asian | 166 (45.4%) | 139 (37.7%) | 108 (29.4%) | < 0.001 |
| Black | 13 (3.6%) | 29 (7.9%) | 21 (5.7%) | |
| Other | 27 (7.4%) | 12 (3.3%) | 12 (3.3%) | |
| White | 160 (43.7%) | 189 (51.2%) | 226 (61.6%) | |
| Body weight (kg) | 76.2 (15.5) | 83.3 (18.0) | 92.0 (21.7) | < 0.001 |
| BMI, kg/m2 | 27.6 (4.6) | 30.2 (5.6) | 32.7 (6.3) | < 0.001 |
| Blood pressure (mmHg) | ||||
| Systolic | 136.6 (16.2) | 137.5 (16.2) | 137.7 (14.6) | 0.338 |
| Diastolic | 75.6 (9.7) | 75.5 (10.3) | 76.6 (9.3) | 0.162 |
| eGFR, ml/min 1.73m2 | 42.4 (12.9) | 41.2 (12.0) | 41.4 (12.2) | 0.311 |
| UACR, mg/g | 888 [514–1773] | 815 [469–1657] | 881 [452–1570] | 0.258 |
| Haemoglobin, g/L | 125.9 (17.3) | 128.8 (17.0) | 131.2 (17.5) | < 0.001 |
| BNP, pg/mL | 51 [27–95] | 46 [23–87] | 44 [26–86] | 0.294 |
| Hematocrit, L/L | 0.38 (0.05) | 0.39 (0.05) | 0.40 (0.05) | < 0.001 |
| CVD history, n (%) | 75 (18.8%) | 82 (21.9%) | 84 (22.2%) | 0.308 |
| Insulin use, n (%) | 136 (37.2%) | 260 (70.5%) | 304 (82.8%) | < 0.001 |
| Diuretic use, n (%) | 282 (77.0%) | 309 (83.7%) | 290 (79.0%) | 0.066 |
| Statin use, n (%) | 272 (74.3%) | 299 (81.0%) | 301 (82.0%) | 0.020 |
Abbreviations: HOMA-IR = Homeostatic Model Assessment for Insulin Resistance; BMI = body mass index; eGFR = estimated glomerular filtration rate; UACR = urine albumin creatinine ratio; BNP = B-type natriuretic peptide; CVD = cardiovascular disease
Note: HOMA-IR: median (min and max values per tertile); UACR and BNP: median (interquartile range); all other numerical values: mean (standard deviation); Regarding p-value for difference: for continues variables linear regression was performed with the variable of interest as dependent variable and IR tertile as numerical covariate to assess the presence of a significant trend across tertiles. For categorical variables a chi-square test was performed to assess the presence of a significant difference in distribution across tertiles