Table 1 Baseline characteristics of the trial population.
Variables | All (n = 164) | P. gingivalis < 0.01% (n = 119) | P. gingivalis ≥ 0.01% (n = 45) | p-value |
---|---|---|---|---|
Demographics | ||||
Age (years) | 57 (15) | 55 (15) | 60 (15) | 0.043 |
Male (%) | 92 (56) | 70 (59) | 22 (49) | 0.255 |
Comorbidities | ||||
Type 2 diabetes (%) | 56 (34) | 41 (34) | 15 (33) | 0.893 |
Hyperlipidemia (%) | 59 (36) | 46 (39) | 13 (29) | 0.248 |
Hypertension (%) | 57 (35) | 43 (36) | 14 (31) | 0.55 |
Hyperuricemia (%) | 15 (9) | 9 (8) | 6 (13) | 0.255 |
Cardiovascular disease (%) | 6 (4) | 6 (5) | 0 (0) | 0.126 |
Thyroid disease (hypothyroidism) (%) | 3 (2) | 2 (2) | 1 (2) | 0.819 |
Concomitant drug use | ||||
Anti-diabetic (%) | 57 (35) | 41 (34) | 16 (35) | 0.896 |
DPP4-inhibitor (%) | 39 (24) | 26 (22) | 13 (29) | 0.348 |
Metformin (%) | 31 (19) | 21 (18) | 10 (22) | 0.507 |
Sulfonylurea (%) | 17 (10) | 11 (9) | 6 (13) | 0.446 |
Anti-lipidemic (%) | 56 (34) | 43 (36) | 13 (29) | 0.386 |
Anti-hypertensive (%) | 56 (34) | 42 (35) | 14 (31) | 0,617 |
Anti-platelet (%) | 0 (0) | 0 (0) | 0 (0) | |
Laxatives, regular use (%) | 0 (0) | 0 (0) | 0 (0) | |
Liver imaging | ||||
CAP on VCTE (dB/m) | 305 (60) | 310 (56) | 295 (69) | 0.168 |
LSM on VCTE (kPa) | 7.7 (4.3) | 7.3 (4.4) | 8.6 (3.8) | 0.114 |
Liver fat content on MRI-PDFF (%) | 12.4 (6.6) | 13.0 (6.6) | 10.8 (6.4) | 0.091 |
Liver stiffness on MRE (kPa) | 3.2 (1.2) | 3.0 (1.3) | 3.7 (1.0) | 0.0064 |
Endotoxin | ||||
EAA (× 102) | 0.1 (0.09) | 0.1 (0.08) | 0.2 (0.08) | 0.001 |
Metabolic factors | ||||
Weight (kg) | 72.6 (15.6) | 73 (16) | 71 (15) | 0.473 |
BMI (kg/m2) | 27 (5.3) | 27.3 (5.0) | 26.1 (6.0) | 0.177 |
Glucose (mg/dL) | 109 (35) | 112 (38) | 101 (26) | 0.093 |
Insulin (μU/mL) | 20 (28) | 21 (31) | 15 (18) | 0.183 |
HOMA-R | 6 (10) | 7 (11) | 4 (8) | 0.2 |
Liver function | ||||
Platelet count | 22 (8) | 22 (9) | 20 (4) | 0.182 |
AST (U/L) | 37 (21) | 35 (21) | 42 (22) | 0.056 |
ALT (U/L) | 50 (38) | 48 (40) | 54 (30) | 0.434 |
GGT (U/L) | 77 (97) | 73 (69) | 86 (147) | 0.447 |
ALP (U/L) | 241 (91) | 238 (88) | 250 (99) | 0.476 |
T.Bil (mg/dL) | 1.2 (4.8) | 1.3 (5.7) | 0.7 (0.3) | 0.428 |
Lipids | ||||
Tcho (mg/dL) | 198 (40) | 199 (38) | 196 (44) | 0.591 |
LDL-C (mg/dL) | 119 (85) | 121 (98) | 112 (35) | 0.56 |
HDL-C (mg/dL) | 43 (82) | 40 (95) | 50 (15) | 0.459 |
TG (mg/dL) | 182 (130) | 189 (143) | 162 (86) | 0.244 |
Inflammatory markers | ||||
hsCRP (mg/L) | 0.2 (0.3) | 0.2 (0.4) | 0.1 (0.2) | 0.512 |
Ferritin (ng/mL) | 233 (187) | 215 (198) | 282 (142) | 0.042 |
Fibrosis marker | ||||
Type IV collagen 7s (ng/mL) | 4.2 (1.0) | 4.2 (1.0) | 4.3 (1.0) | 0.483 |
Periodontal assessment | ||||
PPD (mm) | 2.5 (0.5) | 2.4 (0.5) | 2.7 (0.5) | 0.0091 |
CAL (mm) | 2.5 (0.5) | 2.4 (0.5) | 2.7 (0.5) | 0.0091 |
BOP (site) | 23 (30) | 19 (28) | 32 (31) | 0.0118 |
Stability of teeth | 0 | 0 | 0 | |
PPD ≥ 4 mm (site) | 14 (23) | 12 (22) | 22 (23) | 0.01 |
Oral bacteria, P. gingivalis (× 106 cells/mL) | 0.4 (1.0) | 0.2 (0.5) | 1.2 (1.6) | < 0.0001 |
Antibody titer for P. gingivalis FDC381 | 0.6 (1.8) | 0.5 (1.9) | 0.8 (1.4) | 0.28 |
Antibody titer for P. gingivalis SU63 | 0.9 (2.0) | 0.5 (1.5) | 2.0 (2.6) | < 0.0001 |
IMT mean (R) | 0.9 (0.3) | 0.9 (0.3) | 1.0 (0.3) | 0.0402 |
IMT mean (L) | 0.9 (0.3) | 0.9 (0.2) | 1.0 (0.3) | 0.008 |
IMT max (R) | 1.1 (0.5) | 1.1 (0.5) | 1.2 (0.4) | 0.239 |
IMT max (L) | 1.1 (0.5) | 1.1 (0.6) | 1.2 (0.5) | 0.346 |