Skip to main content

Table 1 Adjusted means and changes in lipoproteins over time by treatment group among completers

From: Impact of a 2-year trial of nutritional ketosis on indices of cardiovascular disease risk in patients with type 2 diabetes

Variables

Visit

Continuous care intervention (n = 194)

Usual care (n = 68)

Between group effect

Mean ± SE

Change from baseline (Mean, CI)

Mean ± SE

Change from baseline (Mean, CI)

Mean difference

95% CI

Total VLDL (nmol/L)

Baseline

138.6 ± 5.7

 

144.0 ± 8.4

 

− 5.3

− 25.4 to 14.8

1 year

128.7 ± 5.8

− 9.9, − 25.8 to 5.9

146.9 ± 8.7

3.0, − 20.3 to 26.2

− 18.2

− 39.0 to 2.5

2 years

129.3 ± 5.9

− 9.3, − 25.3 to 6.6

144.1 ± 8.7

0.2, − 23.0 to 23.4

− 14.8

− 35.7 to 6.0

VLDL large (nmol/L)

Baseline

23.9 ± 1.0

 

22.2 ± 1.7

 

1.7

− 2.3 to 5.7

1 year

19.1 ± 1.0

− 4.8, − 7.6 to − 2.0*

22.7 ± 1.8

0.5, − 4.3 to 5.2

− 3.6

− 7.7 to 0.6

2 years

20.3 ± 1.0

− 3.6, − 6.4 to − 0.8

21.9 ± 1.7

− 0.3, − 5.0 to 4.4

− 1.6

− 5.7 to 2.4

VLDL medium (nmol/L)

Baseline

57.3 ± 1.8

 

55.2 ± 3.1

 

2.1

− 5.2 to 9.3

1 year

52.3 ± 1.8

− 5.0, − 10.0 to 0.0

54.6 ± 3.2

− 0.5, − 9.1 to 8.0

− 2.4

− 9.8 to 5.1

2 years

52.5 ± 1.8

− 4.7, − 9.7 to 0.3

54.7 ± 3.1

− 0.5, − 8.9 to 7.9

− 2.2

− 9.4 to 5.1

VLDL small (nmol/L)

Baseline

59.3 ± 1.5

 

55.8 ± 2.6

 

3.4

− 2.6 to 9.5

1 year

63.2 ± 1.5

3.9, − 0.3 to 8.1

55.0 ± 2.7

− 0.8, − 8.0 to 6.3

8.2

2.0 to 14.4

2 years

59.2 ± 1.5

− 0.1, − 4.3 to 4.1

54.9 ± 2.6

− 0.9, − 8.0 to 6.1

4.3

− 1.8 to 10.4

Total IDL (nmol/L)

Baseline

256.6 ± 8.0

 

255.1 ± 11.9

 

1.6

− 27.0 to 30.1

1 year

285.1 ± 8.3

28.4, 5.9 to 50.9

256.1 ± 12.3

1.1, − 32.0 to 34.1

28.9

− 0.6 to 58.4

2 years

288.9 ± 8.4

32.2, 9.6 to 54.9 Ï

261.5 ± 12.3

6.4, − 26.5 to 39.4

27.3

− 2.3 to 57.0

IDL 1 (nmol/L)

Baseline

136.2 ± 3.3

 

129.2 ± 5.7

 

7.0

− 6.2 to 20.1

1 year

139.4 ± 3.3

3.2, − 5.9 to 12.3

128.8 ± 5.9

− 0.4, − 15.9 to 15.0

10.6

− 2.9 to 24.1

2 years

136.4 ± 3.3

0.2, − 8.9 to 9.2

128.3 ± 5.7

− 0.9, − 16.1 to 14.3

8.0

− 5.1 to 21.1

IDL 2 (nmol/L)

Baseline

122.1 ± 3.8

 

113.3 ± 6.5

 

8.8

− 6.3 to 23.8

1 year

152.1 ± 3.8

30.0, 19.6 to 40.4*

112.0 ± 6.7

− 1.3, − 19.0 to 16.4

40.1*

24.6 to 55.5*

2 years

156.3 ± 3.8

34.2, 23.9 to 44.6*

114.0 ± 6.5

0.7, − 16.7 to 18.1

42.3*

27.2 to 57.3*

Total LDL (nmol/L)

Baseline

991.8 ± 25.9

 

1028.7 ± 40.8

 

− 36.9

− 132.7 to 58.9

1 year

962.7 ± 26.8

− 29.1, − 101.9 to 43.7

1026.5 ± 43.1

− 2.2, − 117.2 to 112.8

− 63.8

− 164.4 to 36.8

2 years

1002.0 ± 27.0

10.3, − 62.8 to 83.4

1022.1 ± 42.3

− 6.6, − 120.2 to 107.0

− 20.0

− 119.6 to 79.6

LDL I (nmol/L)

Baseline

163.5 ± 6.0

 

155.6 ± 10.3

 

7.9

− 16.0 to 31.8

1 year

207.7 ± 6.1

44.2, 27.6 to 60.7*

146.1 ± 10.7

− 9.6, − 37.7 to 18.6

61.7*

37.1 to 86.2*

2 years

211.1 ± 6.0

47.6, 31.1 to 64.0*

152.9 ± 10.3

− 2.8, − 30.4 to 24.9

58.2*

34.3 to 82.1*

LDL IIa (nmol/L)

Baseline

137.8 ± 4.7

 

135.8 ± 8.0

 

2.0

− 16.6 to 20.5

1 year

153.4 ± 4.7

15.6, 2.7 to 28.4

126.5 ± 8.3

− 9.3, − 31.1 to 12.5

26.9

7.8 to 45.9

2 years

156.1 ± 4.7

18.3, 5.5 to 31.1 Ï

129.2 ± 8.0

− 6.6, − 28.0 to 14.8

26.9Ï

8.4 to 45.4Ï

LDL IIb (nmol/L)

Baseline

176.0 ± 5.6

 

170.1 ± 9.5

 

6.0

− 16.1 to 28.0

1 year

169.7 ± 5.6

− 6.3, − 21.6 to 9.0

166.0 ± 9.9

− 4.1, − 30.0 to 21.9

3.7

− 19.0 to 26.3

2 years

174.9 ± 5.6

− 1.1, − 16.3 to 14.2

171.4 ± 9.5

1.3, − 24.3 to 26.9

3.6

− 18.5 to 25.7

LDL IIIa (nmol/L)

Baseline

191.5 ± 7.3

 

169.8 ± 12.6

 

21.7

− 7.4 to 50.8

1 year

157.4 ± 7.4

− 34.0, − 54.2 to − 13.9*

187.2 ± 13.0

17.4, − 16.7 to 51.6

− 29.8

− 59.6 to 0.1

2 years

161.1 ± 7.3

− 30.3, − 50.4 to − 10.3Ï

193.5 ± 12.6

23.8, − 9.9 to 57.4

− 32.4

− 61.5 to − 3.3

LDL IIIb (nmol/L)

Baseline

87.8 ± 4.4

 

84.7 ± 7.6

 

3.1

− 14.6 to 20.7

1 year

66.5 ± 4.5

− 21.2, − 33.5 to − 9.0*

98.0 ± 7.9

13.3, − 7.5 to 34.1

− 31.5*

− 49.6 to − 13.4*

2 years

67.5 ± 4.4

− 20.3, − 32.5 to − 8.1*

96.5 ± 7.6

11.8, − 8.7 to 32.2

− 29.0*

− 46.6 to − 11.3*

LDL IVa (nmol/L)a

Baseline

89.1 ± 3.2

 

95.0 ± 5.6

 

− 5.9

− 18.7 to 6.9

1 year

76.4 ± 3.2

− 12.7, − 21.4 to − 4.0Ï

93.1 ± 5.9

− 1.9, − 17.4 to 13.6

− 16.7

− 30.0 to − 3.4

2 years

76.9 ± 3.2

− 12.2, − 20.9 to − 3.6

89.9 ± 5.6

− 5.1, − 20.2 to 10.1

− 13.1

− 25.9 to − 0.2

LDL IVb (nmol/L)a

Baseline

78.3 ± 1.8

 

82.8 ± 3.2

 

− 4.5

− 11.8 to 2.8

1 year

71.6 ± 1.8

− 6.7, − 11.7 to − 1.7

82.7 ± 3.3

− 0.1, − 8.8 to 8.6

− 11.1Ï

− 18.6 to − 3.6Ï

2 years

73.2 ± 1.8

− 5.1, − 10.1 to − 0.2

81.5 ± 3.2

− 1.3, − 9.9 to 7.5

− 8.3

− 15.6 to − 1.0

LDL IVc (nmol/L)a

Baseline

88.9 ± 1.3

 

89.6 ± 2.2

 

− 0.6

− 5.8 to 4.5

1 year

83.6 ± 1.3

− 5.3, − 8.8 to − 1.7Ï

88.6 ± 2.3

− 0.9, − 7.1 to 5.2

− 5.0

− 10.3 to 0.3

2 years

84.0 ± 1.3

− 5.0, − 8.5 to − 1.4

85.7 ± 2.2

− 3.8, − 9.8 to 2.2

− 1.8

− 6.9 to 3.4

Mid-zone (nmol/L)

Baseline

875.3 ± 8.6

 

892.2 ± 14.7

 

− 16.9

− 50.9 to 17.1

1 year

828.6 ± 8.6

− 46.6, − 70.2 to − 23.1*

890.5 ± 15.2

− 1.7, − 41.8 to 38.3

− 61.8*

− 96.7 to − 26.9*

2 years

815.4 ± 8.6

− 59.9, − 83.4 to − 36.4*

876.0 ± 14.7

− 16.2, − 55.6 to 23.2

− 60.6*

− 94.6 to − 26.5*

Total HDL

Baseline

22.9 ± 0.3

 

25.1 ± 0.5

 

− 2.2

− 3.4 to − 0.9

1 year

22.8 ± 0.4

− 0.2, − 1.1 to 0.8

24.8 ± 0.5

− 0.3, − 1.7 to 1.1

− 2.0

− 3.3 to − 0.7

2 years

22.8 ± 0.4

− 0.1, − 1.1 to 0.9

25.3 ± 0.5

0.2, − 1.2 to 1.6

− 2.5

− 3.8 to − 1.2

HDL 2b (µmol/L)

Baseline

6.0 ± 0.1

 

6.0 ± 0.1

 

0.0

− 0.3 to 0.2

1 year

6.3 ± 0.1

0.4, 0.1 to 0.6Ï

6.0 ± 0.1

− 0.0, − 0.4 to 0.4

0.3

0.0 to 0.7

2 years

6.3 ± 0.1

0.3, 0.1 to 0.5

6.1 ± 0.1

0.1, − 0.3 to 0.5

− 0.1

− 0.2 to 0.5

HDL 2a + 3 (µmol/L)

Baseline

17.3 ± 0.2

 

18.0 ± 0.3

 

− 0.7

− 1.3 to − 0.1

1 year

16.8 ± 0.2

− 0.5, − 0.9 to − 0.0

17.5 ± 0.3

− 0.5, − 1.2 to 0.3

− 0.7

− 1.4 to − 0.0

2 years

17.0 ± 0.2

− 0.3, − 0.8 to 0.1

17.8 ± 0.3

− 0.2, − 0.9 to 0.6

− 0.8

− 1.5 to − 0.2

LDL peak diameters (Å)

Baseline

215.2 ± 0.5

 

215.0 ± 0.8

 

0.2

− 1.7 to 2.1

1 year

219.6 ± 0.5

4.4, 3.1 to 5.7*

215.1 ± 0.8

0.1, − 2.1 to 2.3

4.5*

2.6 to 6.5*

2 years

219.5 ± 0.5

4.3, 3.0 to 5.6*

215.8 ± 0.8

0.8, − 1.4 to 3.0

3.7*

1.8 to 5.6*

  1. Adjusted means and mean changes were obtained from an analysis using linear mixed-effects model (LMM) controlling for baseline age, sex, race, body mass index, HDL 2 + 3a, mid-zone, insulin use and statin use
  2. SE standard error, CI 95% confidence interval, LDL low density lipoprotein, HDL high-density lipoprotein, IDL intermediate density lipoprotein, VLDL very low-density lipoprotein, CIMT carotid intima-media thickness
  3. aVariables normalized by removing the top 1% of values. Analyses were conducted excluding the top 1% values, although all cases were included using the maximum likelihood approach
  4. bVariables normalized by natural log transformation. Non-transformed and unadjusted means, mean changes, CI and standard errors were provided in the table, but the significance level is calculated from the transformed analysis
  5. *P < 0.0015 ensures overall simultaneous significance of P < 0.05 over the 33 variables using Bonferroni correction
  6. ÏP < 0.005