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Table 2 Change in clinical variables after intervention among three arms (n = 422)

From: Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial

Variables 

Control Arma (n = 142) Mean ± SD

Parallel arm Ib (n = 139) Mean ± SD

Parallel arm IIc (n = 141) Mean ± SD

Control versus arm I

Control versus arm II

Baseline

12 month

Baseline

12 month

Baseline

12 month

p value≠

p value≠

FBS (<5.6 mmol/l)

8.13 ± 3.17

7.94 ± 4.10

7.65 ± 2.52

5.18 ± 1.66**

7.71 ± 2.84

6.27 ± 2.19*

0.001

0.01

HbA1c (≤5%)

9.48 ± 1.62

9.44 ± 1.99

8.83 ± 2.41

6.45 ± 1.21**

9.03 ± 1.88

6.93 ± 1.58**

0.001

0.01

BMI (kg/m2)

24.3 ± 3.45

25.1 ± 4.01*

23.5 ± 4.22

24.1 ± 3.45

23.7 ± 5.13

24.4 ± 5.18

0.61

0.78

 Male

27.1 ± 4.05

28.5 ± 3.87

28.5 ± 5.10

28.9 ± 4.08

26.6 ± 5.70

27.1 ± 4.34

0.45

0.53

 Female

23.4 ± 6.03

25.9 ± 5.47*

26.2 ± 5.96

25.67 ± 4.29

24.8 ± 5.79

25.4 ± 5.12

0.39

0.42

BP

      

0.01‡

0.01‡

 (≤130/80 mm Hg)

12–7.9%

25–16.5%

17–11.2%

88–57.9%

13–8.6%

102–67.1%

  

 (>130/80 mm Hg)

140–92.1%

127–83.5%

135–88.8%

64–42.1%

139–91.4%

50–32.9%

  

LDL-c (<2.6 mmol/l)

3.12 ± 0.98

3.56 ± 1.17*

3.09 ± 1.12

2.47 ± 2.11*

3.19 ± 1.19

2.16 ± 0.78**

0.03

0.001

HDL-c (1.0–1.5 mmol/l)

0.98 ± 1.27

0.76 ± 1.02*

1.01 ± 0.87

1.37 ± 1.03*

0.95 ± 1.06

1.39 ± 1.11*

0.01

0.001

Total- c (<5.2 mmol/l)

6.11 ± 2.48

6.44 ± 3.65**

5.97 ± 2.69

5.07 ± 1.49*

6.07 ± 2.71

4.8 ± 1.89**

0.04

0.001

Triglycerides (<1.7 mmol/l)

1.84 ± 1.02

2.11 ± 1.78*

1.91 ± 1.12

1.28 ± 0.67*

1.93 ± 1.09

1.16 ± 0.73**

0.02

0.001

ACR (mg/mmol)

3.79 ± 2.66

3.81 ± 2.03

3.81 ± 2.31

2.32 ± 1.98**

3.80 ± 2.59

3.22 ± 2.06

0.001

0.45

eGFR (>60 ml/min/1.73 m3)

101.21 ± 15.37

97.89 ± 18.20*

107.44 ± 13.84

106.71 ± 13.01

106.32 ± 15.91

107.86 ± 14.37

0.21

0.37

Assessment of risk for diabetes related complicationsd (>3 factors)

High risk

Mean (SD)

High risk

Mean (SD)

High risk

Mean (SD)

Low risk

Mean (SD)

High risk

Mean (SD)

Mod risk

Mean (SD)

0.001

0.01

3.82 (1.81)

4.01* (2.03)

3.90 (1.67)

0.82** (1.01)

4.03 (1.79)

1.67** (0.88)

  

Framingham risk scoree

       

0.001

 Low risk (≤10)

High risk

High risk

High risk

High risk

High risk

Low risk

  

 Moderate risk (10–19)

20.34 ± 3.12

21.42 ± 2.65

21.98 ± 4.41

11.69 ± 2.99**

20.18 ± 4.02

7.23 ± 1.22**

0.01

 

 High risk (≥20)

        

Physical activity

      

0.04‡

0.01‡

 High

–

–

–

15–9.9%

–

19–12.5%

  

 Moderate

54–35.5%

69–45.4%

50–32.9%

71–46.7%

57–37.5%

69–45.4%

  

 Low

98–64.5%

83–54.6%

102–67.1%

66–43.4%

95–62.5%

64–42.1%

  
  1. BP blood pressure, BMI body mass index, HbA1c glycated hemoglobin, FBS fasting blood sugar, LDL-c low density lipoproteins cholesterol, HDL-c high density lipoprotein cholesterol, Total-c total cholesterol, ACR albumin-to-creatinine ratio: Males: <2.5 mg/mmol and females: 3.5 mg/mmol, eGFR estimated glomular filtration rate, IQR interquartile range, Mod moderate
  2. * p < 0.05
  3. ** p < 0.01 (two-tailed) (paired-samples t test)
  4. ≠Independent-samples t test
  5. ‡Chi square
  6. aMetfm with Placebo OD (Blinded)
  7. bMetfm with Ascorbic Acid 500 mg OD (Blinded)
  8. cMetfm with Acetylsalicylic Acid 100 mg OD (Blinded)
  9. dRisk factors: HbA1c, BP, ACR, eGFR, Lipid profile, smoking, medication reviews (regular checkups)
  10. eFramingham Risk score: Cannadian cholerterol guidelines to predict 10-years risk of developing cardiovascular disease—individualize score was calculated first then check for mean ± SD
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Cardiovascular Diabetology

ISSN: 1475-2840