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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