Table 2: Baseline characteristics of 30 patients with type 2 diabetes mellitus.
|
Baseline characteristics |
Treatment group |
Placebo group |
p-value |
All patients (n = 30) |
|
Gender, n (%) |
|
|
0.704a |
|
|
Male |
9 (75.0%) |
12 (66.7%) |
|
21 (70.0) |
|
Female |
3 (25.0%) |
6 (33.3%) |
|
9 (30.0) |
|
Race, n (%) |
|
|
0.212a |
|
|
Malay |
6 (50.0%) |
9 (50.0%) |
|
15 (50.0) |
|
Chinese |
1 (8.5%) |
6 (33.3%) |
|
7 (23.3) |
|
Indian |
5 (41.7%) |
3 (16.7%) |
|
8 (26.7) |
|
Age (years) |
62.00 ± 7.86 |
63.28 ± 8.63 |
0.684b |
62.77 ± 8.22 |
|
Duration of T2DM (years) |
18.17 ± 8.73 |
17.28 ± 5.82 |
0.740b |
17.63 ± 6.70 |
|
HbA1c (%) |
9.30 ± 2.09 |
8.52 ± 1.73 |
0.274b |
8.83 ± 1.89 |
|
SBP (mmHg) |
138.72 ± 16.05 |
135.37 ± 10.19 |
0.489b |
136.71 ± 12.71 |
|
DBP (mmHg) |
75.60 ± 7.83 |
77.97 ± 7.18 |
0.399b |
77.02 ± 7.41 |
|
Weight (kg) |
71.28 ± 15.59 |
73.96 ± 16.36 |
0.659b |
72.89 ± 15.84 |
|
BMI (kg/m2) |
27.35 ± 4.16 |
26.96 ± 4.88 |
0.821b |
27.11 ± 4.53 |
|
Ophthalmological parameters: |
|
|
|
|
|
NPDR grades, n (%) |
|
|
0.461a |
|
|
Mild |
12 (54.5) |
24 (66.7) |
|
36 (62.1) |
|
Moderate |
9 (40.9) |
9 (25.0) |
|
18 (31.0) |
|
Severe |
1 (4.5) |
3 (8.3) |
|
4 (6.9) |
|
Retinal microhaemorrhages/retinal area |
171.07 (341.03) |
81.27 (186.06) |
0.294c |
107.83 (448.69) |
|
Retinal DME/retinal area |
10.71 (20.28) |
2.80 (8.17) |
0.118c |
4.74 (13.87) |
|
Serum α-tocopherol level (umol/L) |
29.98 (37.12) |
44.89 (18.13) |
0.813c |
44.77 (22.41) |
|
Safety tests: |
|
|
|
|
|
ALT (U/L) |
24.50 (14.00) |
19.50 (10.80) |
0.108c |
22.00 (15.50) |
|
AST (U/L) |
23.50 (7.00) |
19.00 (8.30) |
0.112c |
20.00 (10.00) |
|
Total chol (mmol/L) |
4.65 (1.90) |
4.45 (0.80) |
0.249c |
4.50 (1.30) |
|
TG (mmol/L) |
1.45 (1.00) |
1.60 (1.20) |
0.844c |
1.60 (0.90) |
|
HDL (mmol/L) |
1.22 ± 0.24 |
1.19 ± 0.24 |
0.854b |
1.17 ± 0.23 |
|
LDL (mmol/L) |
2.53 ± 0.90 |
2.49 ± 0.74 |
0.402b |
2.55 ± 0.89 |
|
eGFR (ml/min/1.73 m2) |
63.92 ± 23.00 |
69.22 ± 26.30 |
0.983b |
67.85 ± 25.17 |
|
Urea (mmol/L) |
5.00 (1.80) |
6.00 (3.90) |
0.666c |
5.30 (3.30) |
|
Serum Creat (umol/L) |
98.15 (49.30) |
87.50 (37.8) |
0.301c |
95.50 (40.60) |
Values with brackets are median (interquartile range). Plus-minus values are mean ± SD. aFisher's Exact test, more than 20% of the cells have expected value of less than 5; bIndependent t-test, assumptions were fulfilled; cMann-whitney test, data not normally distributed; n: Number of patients; T2DM: Type 2 diabetes mellitus; HbA1c: Haemoglobin A1c; SBP: Systolic blood pressure; DBP: Diastolic blood pressure; BMI: Body mass index; ALT: Alanine aminotransferase; AST: Aspartate transaminase; Total chol: Total cholesterol; TG: Triglycerides; HDL: High density lipoprotein; LDL: Low density lipoprotein; eGFR: estimated glomerular filtration rate; Serum Creat: Serum creatinine.