Table 2.
Change in clinical variables after intervention among three arms (n = 422)
| 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% | ||
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
* p < 0.05
** p < 0.01 (two-tailed) (paired-samples t test)
≠Independent-samples t test
‡Chi square
aMetfm with Placebo OD (Blinded)
bMetfm with Ascorbic Acid 500 mg OD (Blinded)
cMetfm with Acetylsalicylic Acid 100 mg OD (Blinded)
dRisk factors: HbA1c, BP, ACR, eGFR, Lipid profile, smoking, medication reviews (regular checkups)
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