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Table 2 1-year biomarker changes for participants in the continuous care intervention group compared to usual care group

From: Cardiovascular disease risk factor responses to a type 2 diabetes care model including nutritional ketosis induced by sustained carbohydrate restriction at 1 year: an open label, non-randomized, controlled study

  Completers All starters (dropouts imputed)d
N 1 year Mean ± SE Unadjusted Adjusted for baselinec Unadjusted
Difference (SD) or ± SE Significancee Difference ± SE Significancee 1 year Mean ± SE Difference ± SE Significancee
∆Weight-clinic (kg)
 CCI-all educationa 184 101.2 ± 1.6 − 14.2 (10.3) < 10−16 − 13.8 ± 0.6 < 10−16 102.7 ± 1.5 − 13.8 ± 0.7 < 10−16
 Usual carea 69 106.8 ± 2.7 0.04 (5.9) 0.95 − 1.1 ± 1.1 0.29 107.3 ± 2.6 − 0.2 ± 0.8 0.85
 CCI-all vs. usual careb    − 14.3 ± 1.0 < 10−16 − 12.7 ± 1.3 < 10−16   − 13.7 ± 1.1 < 10−16
∆Hemoglobin A1c (%)
 CCI-all educationa 204 6.20 ± 0.07 − 1.29 (1.32) < 10−16 − 1.32 ± 0.09 < 10−16 6.29 ± 0.07 − 1.30 ± 0.09 < 10−16
 Usual carea 72 7.94 ± 0.22 0.20 (1.35) 0.21 0.22 ± 0.16 0.17 7.84 ± 0.19 0.20 ± 0.15 0.18
 CCI-all vs. usual careb    − 1.49 ± 0.18 4.4 × 10−16 − 1.54 ± 0.19 4.4 × 10−16   − 1.50 ± 0.17 < 10−16
∆Systolic blood pressure (mmHg)
 CCI-all educationa 187 126 ± 1 − 7 (16) 1.3 × 10−8 − 7 ± 1 1.6 × 10−7 126 ± 1 − 6 ± 1 1.3 × 10−8
 Usual carea 67 129 ± 2 0 (18) 0.91 0 ± 2 0.83 129 ± 2 − 1 ± 2 0.67
 CCI-all vs. usual careb    − 7 ± 2 0.005 − 6 ± 3 0.02   − 5 ± 2 0.02
∆Diastolic blood pressure (mmHg)
 CCI-all educationa 187 78 ± 1 − 4 (9) 1.4 × 10−7 − 4 ± 1 6.2 × 10−7 79 ± 1  − 4 ± 1 7.2 × 10−8
 Usual carea 67 81 ± 1 0 (10) 0.92 0 ± 1 0.75 81 ± 1 − 1 ± 1 0.45
 CCI-all vs. usual careb    − 3 ± 1 0.01 − 3 ± 1 0.03   − 3 ± 1 0.06
∆ApoB (mg dL−1)
 CCI-all educationa 186 103 ± 2 − 1 (24) 0.69 − 0 ± 2 0.82 104 ± 2 − 2 ± 2 0.37
 Usual carea 59 107 ± 5 2 (37) 0.75 1 ± 4 0.9 106 ± 4 0 ± 4 0.95
 CCI-all vs. usual careb    − 2 ± 5 0.66 − 1 ± 5 0.83   − 2 ± 5 0.67
∆ApoA1 (mg dL−1)
 CCI-all educationa 185 160 ± 3 14 (24) 8.9 × 10−16 14 ± 2 4.4 × 10−16 160 ± 2 14 ± 2 < 10−16
 Usual carea 59 145 ± 3 − 3 (19) 0.18 − 2 ± 3 0.55 147 ± 3 − 2 ± 3 0.37
 CCI-all vs. usual careb    18 ± 3 4.7 × 10−9 16 ± 4 2.2 × 10−5   17 ± 3 1.4 × 10−7
∆ApoB/ApoA1
 CCI-all educationa 185 0.67 ± 0.02 − 0.06 (0.17) 1.8 × 10−6 − 0.06 ± 0.02 0.003 0.67 ± 0.02 − 0.07 ± 0.01 1.9 × 10−7
 Usual carea 59 0.76 ± 0.04 0.03 (0.29) 0.42 0.02 ± 0.03 0.5 0.74 ± 0.03 0.02 ± 0.03 0.58
 CCI-all vs. usual careb    − 0.09 ± 0.04 0.02 − 0.08 ± 0.03 0.02   − 0.09 ± 0.03 0.01
∆Triglycerides (mg dL−1)
 CCI-all educationa 186 151 ± 11 − 49 (168) 5.6 × 10−5 − 50 ± 16 0.001 148 ± 12 − 48 ± 13 < 10−16
 Usual carea 59 327 ± 65 30 (301) 0.44 31 ± 29 0.27 305 ± 48 28 ± 32 0.43
 CCI-all vs. usual careb    − 80 ± 41 0.05 − 81 ± 33 0.02   − 76 ± 35 9.9 × 10−7
∆LDL-C (mg dL−1)
 CCI-all educationa 172 111 ± 3 11 (32) 7.7 × 10−6 11 ± 3 2.6 × 10−5 113 ± 3 10 ± 2 4.9 × 10−5
 Usual carea 48 90 ± 4 − 11 (38) 0.05 − 11 ± 5 0.03 90 ± 5 − 11 ± 5 0.02
 CCI-all vs. usual careb    22 ± 6 0.0003 22 ± 6 0.0002   21 ± 5 9.9 × 10−5
∆HDL-C (mg dL−1)
 CCI-all educationa 186 50 ± 1 8 (12) < 10−16 7 ± 1 < 10−16 50 ± 1 8 ± 1 < 10−16
 Usual carea 59 35 ± 2 − 2 (9) 0.15 − 1 ± 2 0.69 37 ± 2 − 1 ± 1 0.41
 CCI-all vs. usual careb    9 ± 1 1.7 × 10−10 8 ± 2 9.9 × 10−6   9 ± 2 1.2 × 10−8
Triglycerides/HDL-C ratio
 CCI-all educationa 186 4.3 ± 0.6 − 1.8 (9.4) < 10−16 − 1.9 ± 0.9 < 10−16 4.1 ± 0.6 − 1.6 ± 0.7 < 10−16
 Usual carea 59 12.5 ± 2.7 0.9 (16.1) 0.1 1.2 ± 1.6 0.16 11.2 ± 2.1 1.0 ± 1.7 0.24
 CCI-all vs. usual careb    − 2.8 ± 2.2 3.1 × 10−10 − 3.1 ± 1.8 5.5 × 10−7   − 2.6 ± 1.8 4.5 × 10−9
∆Large VLDL-P (nmol L−1)
 CCI-all educationA 203 6 ± 1 − 4 (7) 5.6 × 10−15 − 4 ± 1 1.6 × 10−14 6 ± 1 − 4 ± 1 4.2 × 10−15
 Usual carea 68 12 ± 2 0 (8) 0.71 0 ± 1 0.60 12 ± 1 0 ± 1 0.77
 CCI-all vs. usual careb    − 3 ± 1 0.001 − 3 ± 1 0.002   3 ± 1 0.0007
∆Total LDL-P (nmol L−1)
 CCI-all educationa 203 1234 ± 30 − 62 (375) 0.02 − 57 ± 29 0.05 1235 ± 29 − 64 ± 26 0.02
 Usual carea 68 1196 ± 60 − 47 (491) 0.43 − 67 ± 53 0.21 1231 ± 57 − 57 ± 56 0.31
 CCI-all vs. usual careb    − 15 ± 65 0.82 10 ± 62 0.87   − 7 ± 62 0.91
∆Small LDL-P (nmol L−1)
 CCI-all educationa 203 614 ± 22 − 164 (332) 2.2 × 10−12 − 161 ± 24 4.1 × 10−11 613 ± 21 − 161 ± 23 1.2 × 10−12
 Usual carea 68 724 ± 44 25 (370) 0.57 16 ± 45 0.71 740 ± 41 18 ± 42 0.67
 CCI-all vs. usual careb    − 189 ± 51 0.0002 − 177 ± 52 0.0007   − 179 ± 48 0.0002
∆LDL-particle size (nm)
 CCI-all educationa 201 20.53 ± 0.04 0.23 (0.54) 1.7 × 10−9 0.23 ± 0.04 8.9 × 10−9 20.53 ± 0.04 0.23 ± 0.04 6.0 × 10−10
 Usual carea 68 20.25 ± 0.07 − 0.08 (0.53) 0.24 − 0.08 ± 0.07 0.25 20.25 ± 0.07 − 0.07 ± 0.06 0.25
 CCI-all vs. usual careb    0.30 ± 0.07 4.4 × 10−5 0.31 ± 0.08 0.0002   0.30 ± 0.07 3.8 × 10−15
∆Total HDL-P (µmol L−1)
 CCI-all educationa 203 33.2 ± 0.5 1.5 (4.9) 1.2 × 10−5 1.5 ± 0.4 2.1 × 10−5 32.8 ± 0.4 1.5 ± 0.3 5.6 × 10−6
 Usual carea 68 29.4 ± 0.8 − 0.8 (4.7) 0.15 − 0.8 ± 0.6 0.23 29.2 ± 0.7 − 0.7 ± 0.6 0.23
 CCI-all vs. usual careb    2.3 ± 0.7 0.0004 2.3 ± 0.7 0.003   2.2 ± 0.7 0.0008
∆Large HDL-P (µmol L−1)
 CCI-all educationa 203 5.3 ± 0.2 1.0 (2.2) 2.5 × 10−11 1.0 ± 0.2 4.1 × 10−11 5.3 ± 0.2 1.0 ± 0.2 1.2 × 10−11
 Usual carea 68 3.9 ± 0.3 0.1 (1.6) 0.69 0.2 ± 0.3 0.44 3.9 ± 0.3 0.1 ± 0.2 0.74
 CCI-all vs. usual careb    0.9 ± 0.3 0.0002 0.8 ± 0.3 0.01   0.9 ± 0.3 0.0004
∆LP-IR score
 CCI-all educationa 203 58 ± 2 − 14 (18) < 10−16 − 14 ± 1 < 10−16 58 ± 1 − 14 ± 1 < 10−16
 Usual carea 68 74 ± 2 − 1 (16) 0.73 − 2 ± 2 0.41 75 ± 2 − 1 ± 2 0.74
 CCI-all vs. usual careb    − 13 ± 2 3.8 × 10−9 − 12 ± 3 6.2 × 10−6   − 13 ± 2 6.2 × 10−9
∆C-reactive protein (mg L−1)
 CCI-all educationa 193 5.7 ± 0.5 − 3.3 (13.4) < 10−8 − 3.1 ± 1.0 < 10−16 5.6 ± 0.6 − 3.6 ± 1.1 < 10−16
 Usual carea 70 10.4 ± 1.8 1.3 (13.3) 0.94 0.9 ± 1.7 0.88 10.3 ± 1.6 1.3 ± 1.5 0.93
 CCI-all vs. usual careb    − 4.7 ± 1.9 1.2 × 10−6 − 4.0 ± 2.0 3.0 × 10−5   − 4.9 ± 1.8 9.3 × 10−7
∆WBC (k mm−3)
 CCI-all educationa 204 6.5 ± 0.1 − 0.7 (1.4) 2.1 × 10−11 − 0.7 ± 0.1 2.1 × 10−11 6.6 ± 0.1 − 0.7 ± 0.1 3.2 × 10−11
 Usual carea 72 8.3 ± 0.3 − 0.1 (1.6) 0.76 − 0.1 ± 0.2 0.74 8.1 ± 0.3 − 0.1 ± 0.2 0.76
 CCI-all vs. usual careb    − 0.6 ± 0.2 0.003 − 0.6 ± 0.2 0.004   − 0.6 ± 0.2 0.003
∆10-year ASCVD risk (%)
 CCI-all educationa 135 10.5 ± 0.7 − 1.6 (5.4) 0.0004 − 1.5 ± 0.6 0.01 9.6 ± 0.5 − 1.3 ± 0.3 4.9 × 10−5
 Usual carea 55 12.7 ± 1.5 1.4 (9.3) 0.28 1.1 ± 1.0 0.27 12.9 ± 1.2 1.2 ± 0.9 0.17
 CCI-all vs. usual careb    − 3.0 ± 1.3 0.03 − 2.6 ± 1.2 0.03   − 2.6 ± 1.0 0.008
∆CIMT-average (mm)
 CCI-all educationa 144 0.695 ± 0.009 0.002 (0.055) 0.63 0.003 ± 0.004 0.45 0.685 ± 0.010 0.002 ± 0.004 0.65
 Usual carea 68 0.680 ± 0.013 0.004 (0.041) 0.37 0.002 ± 0.006 0.74 0.680 ± 0.013 0.001 ± 0.006 0.87
 CCI-all vs. usual careb    − 0.002 ± 0.007 0.74 0.001 ± 0.008 0.87   0.001 ± 0.007 0.88
∆Statin (%)
 CCI-all educationa 218 48.2 ± 3.4 − 3.7 (34.4) 0.12 − 3.6 ± 2.4 0.13 46.7 ± 3.2 − 3.3 ± 2.3 0.15
 Usual carea 73 64.4 ± 5.6 9.6 (37.9) 0.03 9.5 ± 4.3 0.03 67.4 ± 5.4 8.8 ± 4.3 0.04
 CCI-all vs. usual careb    − 13.3 ± 5.0 0.008 − 13.2 ± 5.0 0.009   − 12.1 ± 4.9 0.01
∆Any antihypertensive medication (%)
 CCI-all educationa 218 56.4 ± 3.4 − 11.9 (42.3) 3.2 × 10−5 − 11.9 ± 2.9 3.6 × 10−5 55.8 ± 3.3 − 11.4 ± 2.8 5.3 × 10−5
 Usual carea 73 60.3 ± 5.8 9.6 (41.4) 0.05 9.6 ± 5.1 0.06 61.2 ± 5.6 8.3 ± 4.8 0.09
 CCI-all vs. usual careb    − 21.5 ± 5.6 0.0002 − 21.6 ± 6.0 0.0004   − 19.7 ± 5.6 0.0004
∆ACE or ARB (%)
 CCI-all educationa 218 28.9 ± 3.1 0.9 (27.1) 0.62 1.5 ± 1.9 0.42 30.0 ± 2.9 0.6 ± 1.9 0.76
 Usual carea 73 21.9 ± 4.9 5.5 (28.3) 0.1 3.7 ± 3.3 0.27 23.4 ± 4.7 5.0 ± 3.3 0.13
 CCI-all vs. usual careb    − 4.6 ± 3.8 0.23 − 2.1 ± 3.9 0.59   − 4.4 ± 3.8 0.24
∆Diuretics (%)
 CCI-all educationa 218 31.7 ± 3.2 − 9.6 (41.3) 0.0006 − 9.5 ± 2.7 0.0004 31.3 ± 3.1 − 9.7 ± 2.7 0.0004
 Usual carea 73 30.1 ± 5.4 5.5 (32.9) 0.16 5.2 ± 4.8 0.28 33.0 ± 5.3 3.2 ± 4.1 0.44
 CCI-all vs. usual careb    − 15.1 ± 4.8 0.001 − 14.7 ± 5.6 0.009   − 12.8 ± 4.9 0.009
  1. a Means (standard deviations) or ± one standard error are presented. Sample sizes, means, and significance levels refer to subjects with baseline and 1-year measurements for completers, and to 349 subjects (262 intervention and 87 usual care) for all starters. Significance levels for completers refer to one-sample t test with or without adjustment. Untransformed triglyceride and C-reactive protein values are presented, however, their statistical significances were based on their log-transformed values
  2. b Mean differences ± one standard error are presented. Significance levels refer to two-sample t test or analysis of covariance for the differences
  3. c Adjusted for sex, age, baseline BMI, baseline insulin use (user vs. non-user), and African–American race
  4. d Imputed values based on 700 iterations from multivariate normal regression
  5. e A significance level of P < 0.0019 ensures overall simultaneous significance of P <  0.05 over the 26 variables using Bonferroni correction