Table 2 (a) Final measurements at 6 months with comparisons between Vitamin E and placebo group and results of interaction test with haptoglobin genotype. (b) Subgroup analysis of final measurements at 6 months with comparisons between haptoglobin genotype and Vitamin E and placebo group.

From: Impact of Vitamin E supplementation on vascular function in haptoglobin genotype stratified diabetes patients (EVAS Trial): a randomised controlled trial

Variables

Overall

Interaction test

Vitamin E

Placebo

Diff (95% CI)

p value

Hp 2-2

Non-Hp 2-2

p value

Vitamin E

Placebo

Vitamin E

Placebo

(a) Final measurements at 6 months with comparisons between Vitamin E and placebo group and results of interaction test with haptoglobin genotype

Number (%)

84 (50.6)

82 (49.4)

  

42 (25.30)

44 (26.51)

42 (25.30)

38 (22.89)

 

Time from baseline to completion visit days, Median (IQR)

176.00 (12.00)

177.00 (14.00)

 

0.329b

176.50 (13.00)

177.00 (14.00)

175.50 (12.00)

177.00 (14.00)

 

Physical measurements

BMI Kg/m2, mean (SD)

27.55 (4.93)

27.23 (5.03)

−0.32 (−1.84, 1.21)

0.684a

27.79 (5.33)

27.96 (5.36)

27.30 (4.54)

26.39 (4.54)

0.482f

Waist circumference cm, mean (SD)

92.97 (10.27)

94.10 (11.18)

1.12 (−2.16, 4.41)

0.500a

91.78 (9.94)

95.17 (11.11)

94.17 (10.57)

92.85 (11.30)

0.160f

Systolic BP (Peripheral) mmHg, mean (SD)

133.27 (15.05)

129.62 (13.51)

−3.66 (−8.04, 0.73)

0.102a

133.21 (13.63)

128.92 (14.08)

133.33 (16.51)

130.42 (12.96)

0.758f

Diastolic BP (Peripheral) mmHg, mean (SD)

74.18 (8.66)

71.95 (6.90)

−2.23 (−4.63, 0.18)

0.069a

74.61 (8.30)

72.78 (7.51)

73.75 (9.09)

70.99 (6.07)

0.701f

Metabolic parameters

HbA1c %, mean (SD)

7.75 (1.19)

7.99 (1.37)

0.25 (−0.15, 0.64)

0.219a

7.79 (1.26)

8.29 (1.67)

7.70 (1.13)

7.65 (0.80)

0.169f

Total cholesterol mmol/L, Median (IQR)

4.10 (1.08)

3.90 (1.30)

−0.20 (−0.52, 0.12)

*0.034b

4.30 (1.23)

4.20 (1.10)

4.10 (0.93)

3.60 (1.25)

0.303f

LDL cholesterol mmol/L, Median (IQR)

2.40 (0.83)

2.10 (1.00)

−0.30 (−0.52, −0.08)

*0.014b

2.40 (1.13)

2.30 (0.80)

2.30 (0.70)

1.90 (0.75)

0.569f

HDL cholesterol mmol/L, Median (IQR)

1.10 (0.40)

1.10 (0.30)

0.00 (−0.08, 0.08)

0.628b

1.10 (0.23)

1.10 (0.28)

1.10 (0.40)

1.10 (0.30)

0.960f

Triglycerides mmol/L, Median (IQR)

1.40 (1.15)

1.20 (1.10)

−0.20 (−0.51, 0.11)

0.348b

1.35 (0.75)

1.30 (1.25)

1.40 (1.30)

1.10 (0.90)

0.069f

Renal parameters

Creatinine μmol/L, mean (SD)

71.69 (19.97)

78.59 (25.01)

6.91 (−1.13, 14.94)

0.092a

66.52 (18.89)

78.27 (24.62)

77.03 (19.95)

78.94 (25.82)

0.225f

eGFR ml/min/1.72m2, mean (SD)

93.07 (17.33)

84.62 (21.44)

−8.46 (−15.35, −1.57)

*0.017a

97.49 (16.75)

85.18 (22.97)

88.51 (16.99)

84.02 (20.06)

0.263f

ACR mg/mmol, Median (IQR)

1.50 (3.45)

2.20 (4.30)

0.70 (−0.81, 2.21)

0.147b

1.25 (3.18)

1.75 (5.45)

2.15 (4.63)

2.90 (4.25)

0.484f

Haematological parameters

Haptoglobin mg/dL, mean (SD)

109.67 (52.03)

115.76 (48.14)

6.09 (−9.28, 21.46)

0.435a

98.98 (44.44)

101.50 (39.12)

120.36 (57.20)

132.26 (52.66)

0.536f

Ferritin μg/L, Median (IQR)

72.00 (83.00)

58.50 (93.00)

−13.50 (−40.01, 14.01)

0.322b

57.50 (70.00)

58.50 (107.00)

79.00 (94.00)

58.00 (90.00)

0.213f

Transferrin g/L, mean (SD)

91.42 (77.24)

85.26 (78.16)

−6.16 (−29.98, 17.66)

0.610a

2.51 (0.40)

2.46 (0.36)

2.35 (0.41)

2.46 (0.40)

0.210f

Fe Concentration μmol/L, mean (SD)

12.89 (5.30)

12.75 (4.48)

−0.15 (−1.86, 1.57)

0.865a

12.90 (4.87)

11.72 (4.68)

12.89 (5.73)

13.81 (4.07)

0.226f

Alpha-tocopherol, μg/ml,Median (IQR)

44.02 (44.32)

43.20 (36.74)

−1.02 (−13.54, 11.51)

0.682b

38.25 (38.04)

39.22 (33.56)

52.04 (46.30)

45.53 (44.10)

0.829f

Vascular markers

hsCRP mg/L, Median (IQR)

1.45 (2.95)

1.50 (2.50)

0.05 (−0.76, 0.76)

0.982b

1.90 (3.08)

1.4 (2.95)

1.20 (1.93)

1.65 (2.43)

0.356f

dROMS, Median (IQR)

275.00 (85.00)

275.50 (115.00)

0.50 (−18.87, 22.87)

0.768b

293.50 (87.00)

270.5 (120.00)

266.50 (85.00)

280.50 (115.0)

0.226f

BAPs uM, Median (IQR)

2231.00 (311.0)

2191.50 (354.0)

−39.50 (−125.63, 51.63)

0.836b

2218.0 (315.00)

2192.5 (393.00)

2252.5 (326.0)

2186.5 (418.0)

0.458f

CIMT: Average of left and right mm, mean (SD)

0.67 (0.14)

0.67 (0.12)

−0.004 (−0.04, 0.04)

0.822a

0.66 (0.12)

0.67 (0.13)

0.69 (0.15)

0.67 (0.12)

0.531f

CIMT: Maximum of left and right mm, mean (SD)

0.82 (0.16)

0.81 (0.15)

−0.01 (−0.06, 0.04)

0.737a

0.80 (0.14)

0.81 (0.15)

0.84 (0.18)

0.82 (0.15)

0.558f

EndoPAT: LnRHI, mean (SD)

0.66 (0.27)

0.65 (0.25)

−0.02 (−0.10, 0.06)

0.690a

0.64 (0.26)

0.68 (0.23)

0.69 (0.28)

0.61 (0.26)

0.128f

EndoPAT: Augmentation index 75bpm%,mean (SD)

20.23 (17.52)

15.89 (12.03)

−4.34 (−8.94, 0.26)

0.064a

19.90 (16.66)

18.48 (13.23)

20.55 (18.53)

12.89 (9.80)

0.184f

Pulse Wave Analysis: Systolic BP mmHg, mean (SD)

118.98 (14.42)

115.32 (12.18)

−3.66 (−7.75, 0.44)

0.079a

119.62 (12.64)

115.95 (12.32)

118.33 (16.13)

114.58 (12.13)

0.983f

Pulse Wave Analysis: Diastolic BP mmHg,mean (SD)

77.81 (9.76)

75.70 (8.38)

−2.11 (−4.91, 0.68)

0.137a

77.83 (8.68)

76.59 (8.51)

77.79 (10.84)

74.66 (8.22)

0.508f

Pulse Wave Velocity m/s, mean (SD)

8.48 (1.58)

8.41 (1.64)

−0.07 (−0.56, 0.42)

0.776a

8.34 (1.56)

8.51 (1.72)

8.62 (1.61)

8.29 (1.55)

0.330f

SphygmoCor: Augmentation index %, mean (SD)

29.71 (13.77)

29.26 (9.96)

−0.46 (−4.15, 3.24)

0.808a

30.85 (9.07)

29.48 (9.77)

28.60 (17.21)

29.00 (10.31)

0.637f

Oxidised LDL IU/L, Median (IQR)

55.30 (23.98)

61.35 (25.16)

−6.05 (−15.22, 2.97)

*0.033b

62.10 (23.55)

59.88 (23.80)

60.11 (27.86)

49.22 (21.50)

0.309f

Variables

Hp 2-2

Non-Hp 2-2

Vitamin E

Placebo

Diff (95% CI)

p value

Vitamin E

Placebo

Diff (95% CI)

p value

(b) Subgroup analysis of final measurements at 6 months with comparisons between haptoglobin genotype and Vitamin E and placebo group

Number (%)

42 (25.30)

44 (26.51)

  

42 (25.30)

38 (22.89)

  

Time from baseline to completion visit days, Median (IQR)

176.50 (13.00)

177.00 (14.00)

 

0.595b

175.50 (12.00)

177.00 (14.00)

 

0.417b

Physical measurements

BMI Kg/m2, mean (SD)

27.79 (5.33)

27.96 (5.36)

0.17 (−2.12, 2.46)

0.882a

27.30 (4.54)

26.39 (4.54)

−0.92 (−2.94, 1.11)

0.370a

Waist circumference cm, mean (SD)

91.78 (9.94)

95.17 (11.11)

3.39 (−1.14, 7.92)

0.140a

94.17 (10.57)

92.85 (11.30)

−1.31 (−6.18, 3.55)

0.592a

Systolic BP (Peripheral) mmHg, mean (SD)

133.21 (13.63)

128.92 (14.08)

−4.29 (−10.24, 1.65)

0.155a

133.33 (16.51)

130.42 (12.96)

−2.91 (−9.57, 3.74)

0.386a

Diastolic BP (Peripheral) mmHg, mean (SD)

74.61 (8.30)

72.78 (7.51)

−1.82 (−5.21, 1.57)

0.288a

73.75 (9.09)

70.99 (6.07)

−2.76 (−6.24, 0.72)

0.118a

Metabolic parameters

HbA1c %, mean (SD)

7.79 (1.26)

8.29 (1.67)

0.49 (−0.14, 1.13)

0.127a

7.70 (1.13)

7.65 (0.80)

−0.05 (−0.49, 0.39)

0.820a

Total cholesterol mmol/L, Median (IQR)

4.30 (1.23)

4.20 (1.10)

−0.10 (−0.59, 0.39)e

0.473b

4.10 (0.93)

3.60 (1.25)

−0.50 (−0.94, −0.06)e

*0.016b

LDL cholesterol mmol/L, Median (IQR)

2.40 (1.13)

2.30 (0.80)

−0.10 (−0.52, 0.32)e

0.410b

2.30 (0.70)

1.90 (0.75)

−0.40 (−0.72, −0.08)e

*0.006b

HDL cholesterol mmol/L, Median (IQR)

1.10 (0.23)

1.10 (0.28)

0.00 (−0.10, 0.10)e

0.972b

1.10 (0.40)

1.10 (0.30)

0.00 (−0.15, 0.15) e

0.478b

Triglycerides mmol/L, Median (IQR)

1.35 (0.75)

1.30 (1.25)

−0.05 (−0.49, 0.29)e

0.819b

1.40 (1.30)

1.10 (0.90)

−0.30 (−0.83, 0.23)e

0.110b

Renal parameters

Creatinine μmol/L, mean (SD)

66.52 (18.89)

78.27 (24.62)

11.76 (0.74, 22.77)

*0.037a

77.03 (19.95)

78.94 (25.82)

1.90 (−9.95,13.75)

0.749a

eGFR ml/min/1.72m2, mean (SD)

97.49 (16.75)

85.18 (22.97)

−12.32 (−22.42,−2.22)

*0.017a

88.51 (16.99)

84.02 (20.06)

−4.48 (−14.02,5.06)

0.351a

ACR mg/mmol, Median (IQR)

1.25 (3.18)

1.75 (5.45)

0.50 (−1.53, 2.73)e

0.093b

2.15 (4.63)

2.90 (4.25)

0.75 (−0.46, 2.86)e

0.691b

Haematological parameters

Haptoglobin mg/dL, mean (SD)

98.98 (44.44)

101.50 (39.12)

2.52 (−15.41, 20.46)

0.780a

120.36 (57.20)

132.26 (52.66)

11.91 (12.65,36.4)

0.337a

Ferritin μg/L, Median (IQR)

57.50 (70.00)

58.50 (107.00)

1.0 (−33.55, 37.55)e

0.701b

79.00 (94.00)

58.00 (90.00)

21.0 (−60.28,22.28)e

0.089b

Transferrin g/L, mean (SD)

2.51 (0.40)

2.46 (0.36)

−0.04 (−0.21, 0.12)

0.597a

2.35 (0.41)

2.46 (0.40)

0.11 (−0.07, 0.29)

0.228a

Fe Concentration μmol/L, mean (SD)

12.90 (4.87)

11.72 (4.68)

−1.18 (−3.59, 1.22)

0.329a

12.89 (5.73)

13.81 (4.07)

0.92 (−1.55, 3.40)

0.460a

Alpha-tocopherol, μg/ml,Median (IQR)

38.25 (38.04)

39.22 (33.56)

0.97 (−15.21,16.98)e

0.789b

52.04 (46.30)

45.53 (44.10)

−6.51 (−27.12,13.4)e

0.765b

Vascular markers

hsCRP mg/L, Median (IQR)

1.90 (3.08)

1.4 (2.95)

−0.50 (−1.74, 0.74)e

0.441b

1.20 (1.93)

1.65 (2.43)

0.45 (−0.48, 1.48)e

0.390b

dROMS, Median (IQR)

293.50 (87.00)

270.5 (120.00)

−23.0 (−59.08, 25.08)e

0.267b

266.50 (85.00)

280.50 (115.0)

14.0 (−28.45,50.45)e

0.544b

BAPs uM, Median (IQR)

2218.0 (315.00)

2192.5 (393.00)

−25.5 (−169.9,105.87)e

0.717b

2252.5 (326.0)

2186.5 (418.0)

−66.0 (−206.8,87.8)e

0.965b

CIMT: Average of left and right mm, mean (SD)

0.66 (0.12)

0.67 (0.13)

0.01 (−0.05, 0.06)

0.754a

0.69 (0.15)

0.67 (0.12)

−0.02 (−0.08, 0.04)

0.579a

CIMT: Maximum of left and right mm, mean (SD)

0.80 (0.14)

0.81 (0.15)

0.01 (−0.06, 0.07)

0.839a

0.84 (0.18)

0.82 (0.15)

−0.02 (−0.09, 0.05)

0.556a

EndoPAT: LnRHI, mean (SD)

0.64 (0.26)

0.68 (0.23)

0.04 (−0.06, 0.15)

0.418a

0.69 (0.28)

0.61 (0.26)

−0.08 (−0.20, 0.04)

0.194a

EndoPAT: Augmentation index 75bpm%,mean (SD)

19.90 (16.66)

18.48 (13.23)

−1.43 (−7.86, 5.01)

0.660a

20.55 (18.53)

12.89 (9.80)

−7.65 (−14.36,−0.95)

*0.022a

Pulse Wave Analysis: Systolic BP mmHg, mean (SD)

119.62 (12.64)

115.95 (12.32)

−3.67 (−9.02, 1.69)

0.177a

118.33 (16.13)

114.58 (12.13)

−3.75 (−10.16,2.65)

0.247a

Pulse Wave Analysis: Diastolic BP mmHg,mean (SD)

77.83 (8.68)

76.59 (8.51)

−1.24 (−4.93, 2.45)

0.505a

77.79 (10.84)

74.66 (8.22)

−3.13 (−7.45, 1.19)

0.153a

Pulse Wave Velocity m/s, mean (SD)

8.34 (1.56)

8.51 (1.72)

0.17 (−0.54, 0.87)

0.641a

8.62 (1.61)

8.29 (1.55)

−0.32 (−1.03, 0.38)

0.362a

SphygmoCor: Augmentation index %, mean (SD)

30.85 (9.07)

29.48 (9.77)

−1.38 (−5.45, 2.70)

0.503a

28.60 (17.21)

29.00 (10.31)

0.41 (−6.00, 6.81)

0.900a

Oxidised LDL IU/L, Median (IQR)

62.10 (23.55)

59.88 (23.80)

−2.22 (−11.43,7.05)e

0.484b

60.11 (27.86)

49.22 (21.50)

−10.89 (−22.2,−0.75) e

*0.012b

  1. DM Diabetes mellitus, BMI body mass index, BP blood pressure, eGFR estimated glomerular filtration rate by CKD-EPI formula, ACR albumin creatinine ratio, LDL-C low density lipoprotein cholesterol, HDL-C high density lipoprotein cholesterol, Fe iron, hsCRP highly sensitive c-reactive protein, dROMS derivatives of reactive-oxygen species, BAP Biological antioxidant potential, CIMT carotid artery intima media thickness, LnRHI log reactive-hyperaemia index.
  2. aIndependent Sample T test.
  3. bMann–Whitney U test.
  4. cPearson Chi-Square test.
  5. dFisher Exact test.
  6. eThe median difference was derived by quantile regression.
  7. fInteraction test between hp genotype and Vitamin E placebo group. *P < 0.05.