Table 3.
MRI measure | Intensive | Standard | Difference in Change | P-value for interaction by UACR | ||||
---|---|---|---|---|---|---|---|---|
| ||||||||
Baseline (95% CI) | Follow-up (95% CI) | Change (95% CI) | Baseline (95% CI) | Follow-up (95% CI) | Change (95% CI) | (95% CI) | ||
Total cerebral blood flow (mL/100 g/min) | ||||||||
UACR <30 | 36.02 (32.9, 39.14) | 37.73 (34.48, 40.98) | 1.71 (0.26, 3.15) | 35.83 (32.67, 38.99) | 34.86 (31.54, 38.17) | −0.97 (−2.53, 0.58) | 2.68 (0.57, 4.79) | 0.8 |
UACR ≥30 | 38.71 (34.3, 43.13) | 38.02 (33.01, 43.02) | −0.69 (−4.12, 2.73) | 36.7 (32.18, 41.22) | 34.1 (28.99, 39.21) | −2.6 (−6.14, 0.93) | 1.91 (−3.01, 6.82) | |
WML volume, asinh (cm3) | ||||||||
UACR <30 | 1.93 (1.82, 2.04) | 2.06 (1.95, 2.17) | 0.13 (0.08, 0.17) | 1.88 (1.76, 2) | 2.16 (2.03, 2.28) | 0.28 (0.23, 0.33) | −0.15 (−0.22, −0.09) | 0.04 |
UACR ≥30 | 2.34 (2.11, 2.57) | 2.57 (2.33, 2.81) | 0.23 (0.14, 0.32) | 2.25 (2, 2.5) | 2.48 (2.22, 2.74) | 0.23 (0.13, 0.32) |
0.003 (−0.13, 0.13) | |
Total brain volume (cm3) | ||||||||
UACR <30 | 1129.7 (1116.5, 1142.8) | 1099.7 (1086.5, 1112.9) | −29.9 (−31.8, −28.0) | 1126.5 (1113.1, 1139.9) | 1098.8 (1085.3, 1112.2) | −27.8 (−29.9, −25.6) | −2.2 (−5.0, 0.7) | 0.1 |
UACR ≥30 | 1115.5 (1095,0 1136.1) | 1085.9 (1065.2, 1106.7) | −29.6 (−33.8, −25.4) | 1116.8 (1095.7, 1137.9) | 1094.2 (1072.9, 1115.5) | −22.6 (−27.1, −18.0) | −7.0 (−13.3, −0.8) |
Interaction p-value is testing the difference in change between UACR groups. Estimates are based on a linear mixed model adjusting for intracranial volume (except in CBF models) and days since randomization, with random effects for participant and MRI facility. Estimates represent least squares means, with follow-up estimated computed at 1452 days (3.98 years) post-randomization. For change estimates, negative values denote decreases from baseline, while positive values indicating increases from baseline. Difference in change represents intensive treatment group minus standard treatment group.
There were N=645, 687, and 690 participants included in the cerebral blood flow, WML volume, and brain volume analyses, respectively.
Abbreviations: asinh inverse hyperbolic sine transformation, f(x) = log(x + (x2 + 1)0.5), eGFR – estimated glomerular filtration rate, MRI – magnetic resonance imaging, SE - standard error, CI - confidence interval, WML - white matter lesion UACR is expressed as mg/g