. | All patients . | Normoalbuminuria . | Albuminuria . | P value¶ . |
---|---|---|---|---|
. | (N = 1,181) . | (n = 681) . | (n = 500) . | |
Characteristics at baseline | ||||
Age, years | 57 (50; 62) | 57 (51; 62) | 57 (50; 61) | 0.110 |
Men, % | 58 | 48 | 71 | <0.0001 |
Duration of diabetes, years | 10 (6; 15) | 10 (7; 15) | 10 (5; 15) | 0.066 |
BMI, kg/m2 | 31 (27; 36) | 30 (26; 35) | 32 (29; 37) | <0.0001 |
Systolic BP, mmHg | 131 (120; 142) | 130 (120; 140) | 134 (122; 145) | <0.0001 |
ACE inhibitor or ARB Rx, % | 65 | 55 | 79 | <0.0001 |
Insulin Rx, % | 57 | 60 | 53 | 0.021 |
HbA1c, % | 7.6 (6.9; 8.6) | 7.5 (6.8; 8.3) | 7.8 (6.9; 9.0) | <0.0001 |
eGFR, mL/min/1.73 m2 | 96 (83; 105) | 95 (84; 105) | 97 (82; 106) | 0.392 |
Baseline ACR, mg/g | 13 (6; 42) | 7 (5; 11) | 53 (26; 159) | <0.0001 |
Biomarkers at baseline | ||||
Profibrotic proteins | ||||
Serum WFDC2, ng/mL | 6.7 (5.6; 8.4) | 6.5 (5.4; 7.9) | 6.7 (5.9; 9.4) | <0.0001 |
Serum MMP-7, ng/mL | 3.9 (3.0; 5.1) | 3.5 (2.7; 4.5) | 4.2 (3.4; 6.0) | <0.0001 |
Other biomarkers† | ||||
Plasma TNFR-1, pg/mL | 1,250 (1,048; 1,603) | 1,183 (993; 1,450) | 1,404 (1,140; 1,880) | <0.0001 |
Plasma KIM-1, pg/mL | 10 (5; 17) | 9 (5; 13) | 13 (6; 22) | <0.0001 |
Urinary EGF–to–MCP-1 ratio | 39 (24; 76) | 46 (27; 102) | 33 (20; 54) | <0.0001 |
Outcomes during 6–12 years of follow-up | ||||
eGFR slope, mL/min/1.73 m2/year | −1.6 (−3.3; −0.5) | −1.2 (−2.4; −0.3) | −2.2 (−4.2; −0.9) | <0.0001 |
Fast renal decliner§, n (%) | 152 (12.9) | 47 (6.9) | 105 (21.0) | <0.0001 |
Incidence of ESKD, n (%) | 33 (2.7) | 3 (0.4) | 30 (6.0) | <0.0001 |
Deaths unrelated to ESKD, n (%) | 13 (1.0) | 6 (0.9) | 7 (1.4) | 0.398 |
. | All patients . | Normoalbuminuria . | Albuminuria . | P value¶ . |
---|---|---|---|---|
. | (N = 1,181) . | (n = 681) . | (n = 500) . | |
Characteristics at baseline | ||||
Age, years | 57 (50; 62) | 57 (51; 62) | 57 (50; 61) | 0.110 |
Men, % | 58 | 48 | 71 | <0.0001 |
Duration of diabetes, years | 10 (6; 15) | 10 (7; 15) | 10 (5; 15) | 0.066 |
BMI, kg/m2 | 31 (27; 36) | 30 (26; 35) | 32 (29; 37) | <0.0001 |
Systolic BP, mmHg | 131 (120; 142) | 130 (120; 140) | 134 (122; 145) | <0.0001 |
ACE inhibitor or ARB Rx, % | 65 | 55 | 79 | <0.0001 |
Insulin Rx, % | 57 | 60 | 53 | 0.021 |
HbA1c, % | 7.6 (6.9; 8.6) | 7.5 (6.8; 8.3) | 7.8 (6.9; 9.0) | <0.0001 |
eGFR, mL/min/1.73 m2 | 96 (83; 105) | 95 (84; 105) | 97 (82; 106) | 0.392 |
Baseline ACR, mg/g | 13 (6; 42) | 7 (5; 11) | 53 (26; 159) | <0.0001 |
Biomarkers at baseline | ||||
Profibrotic proteins | ||||
Serum WFDC2, ng/mL | 6.7 (5.6; 8.4) | 6.5 (5.4; 7.9) | 6.7 (5.9; 9.4) | <0.0001 |
Serum MMP-7, ng/mL | 3.9 (3.0; 5.1) | 3.5 (2.7; 4.5) | 4.2 (3.4; 6.0) | <0.0001 |
Other biomarkers† | ||||
Plasma TNFR-1, pg/mL | 1,250 (1,048; 1,603) | 1,183 (993; 1,450) | 1,404 (1,140; 1,880) | <0.0001 |
Plasma KIM-1, pg/mL | 10 (5; 17) | 9 (5; 13) | 13 (6; 22) | <0.0001 |
Urinary EGF–to–MCP-1 ratio | 39 (24; 76) | 46 (27; 102) | 33 (20; 54) | <0.0001 |
Outcomes during 6–12 years of follow-up | ||||
eGFR slope, mL/min/1.73 m2/year | −1.6 (−3.3; −0.5) | −1.2 (−2.4; −0.3) | −2.2 (−4.2; −0.9) | <0.0001 |
Fast renal decliner§, n (%) | 152 (12.9) | 47 (6.9) | 105 (21.0) | <0.0001 |
Incidence of ESKD, n (%) | 33 (2.7) | 3 (0.4) | 30 (6.0) | <0.0001 |
Deaths unrelated to ESKD, n (%) | 13 (1.0) | 6 (0.9) | 7 (1.4) | 0.398 |
Data are presented as the median (Q1; Q3) or as indicated. Subgroups of normoalbuminuria (ACR <30 mg/g) and albuminuria (ACR ≥30 mg/g) were determined according to the median values of ACR from two or more consecutive urine samples obtained during the 2-year period preceding enrollment (baseline). Rx, treatment.
P value for comparison of patients with normoalbuminuria versus albuminuria. †Our previous publication included biomarkers of inflammation and tubular damage, which were associated with early progressive renal decline: plasma TNF-R1, plasma KIM-1, and urinary EGF–to–MCP-1 ratio (23). §Fast renal decline is defined as eGFR loss ≥5 mL/min/1.73 m2/year calculated over a median 7-year follow-up.