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Table 1 Demographic and clinical variables at baseline (randomization) in all three arms (n = 456)

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 = 152)

Parallel arm Ib (n = 152)

Parallel arm IIc (n = 152)

X 2 /t

p value 

Mean (SD)/percent

Mean (SD)/percent

Mean (SD)/percent

A. Demographic

 Age (years)

37.93

(7.89)

38.12

(8.16)

37.49

(6.72)

0.08

0.87≠

 Gender

      

0.02

0.13‡

  Male

93

61.2%

90

59.2%

95

62.5%

  

  Female

59

38.8%

62

40.8%

57

37.5%

  

B. Clinical variables

 Duration of diabetes (yrs)

2.87

(1.22)

2.47

(2.48)

3.02

(1.97)

0.07

0.36≠

 FBS (<5.6 mmol/l)

8.13

(3.17)

7.65

(2.52)

7.71

(2.84)

0.94

0.27≠

 HbA1c (≤5%)

9.48

(1.62)

8.83

(2.41)

9.03

(1.88)

0.71

0.45≠

 BMI (kg/m2)

24.3

(3.45)

23.5

(4.22)

23.7

(5.13)

0.59

0.74≠

  Male

27.1

(4.05)

28.5

(5.10)

26.6

(5.70)

1.02

0.24≠

  Female

23.4

(6.03)

26.2

(5.96)

24.8

(5.79)

2.07

0.38≠

 Smoker

      

0.26

0.16‡

  Ever smoke (ES)

15

9.9%

21

13.9%

19

12.5%

  

  Never smoke (NS)

137

90.1%

143

94.1%

133

87.5%

  

 BP

      

0.11

0.29‡

  (≤130/80 mm Hg)

12

7.9%

17

11.2%

13

8.6%

  

  (>130/80 mm Hg)

140

92.1%

135

88.8%

139

91.4%

  

 Waist circumferences (cm)

94

(10.01)

93

(10.44)

95

(12.44)

0.65

0.71≠

 LDL-c (< 2.6 mmol/l)

3.12

(0.98)

3.09

(1.12)

3.19

(1.19)

0.21

0.48≠

 HDL-c (1.0–1.5 mmol/l)

0.98

(1.27)

1.01

(0.87)

0.95

(1.06)

0.31

0.62≠

 Total- c (<5.2 mmol/l)

6.11

(2.48)

5.97

(2.69)

6.07

(2.71)

0.73

0.77≠

 Triglycerides (<1.7 mmol/l)

1.84

(1.02)

1.91

(1.12)

1.93

(1.09)

0.67

0.35≠

 ACR (mg/mmol)*

3.79

(2.66)

3.81

(2.31)

3.80

(2.59)

0.98

0.98≠

 eGFR (>60 ml/min/1.73 m3)

101.21

(15.37)

107.44

(13.84)

106.32

(15.91)

0.61

0.81≠

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

Mean (SD)

Mean (SD)

Mean (SD)

0.85

0.61≠

3.82 (1.81)

3.90 (1.67)

4.03 (1.79)

  

High risk

High risk

High risk

  

 Framingham risk scoree

Mean (SD)

Mean (SD)

Mean (SD)

0.71

0.32≠

  Low risk (≤10)

20.34 (3.12)

21.98 (4.41)

20.18 (4.02)

  

  Moderate risk (10–19)

High risk

High risk

High risk

  

  High risk (≥20)

     

 Physical activity

   

0.91

0.49‡

  High

–

–

–

  

  Moderate

54 (35.5%)

50 (32.9%)

57 (37.5%)

  

  Low

98 (64.5%)

102 (67.1%)

95 (62.5%)

  
  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, eGFR estimated glomular filtration rate, IQR interquartile range
  2. ≠One way—ANOVA
  3. ‡Chi square
  4. aMetfm with placebo OD (Blinded)
  5. bMetfm with ascorbic acid 500 mg OD (Blinded)
  6. cMetfm with acetylsalicylic acid 100 mg OD (blinded), * Males: <2.5 mg/mmol & females: 3.5 mg/mmol
  7. dRisk factors: HbA1c, BP, ACR, eGFR, Lipid profile, smoking, medication reviews (regular checkups)
  8. 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