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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
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Cardiovascular Diabetology

ISSN: 1475-2840