Baseline Characteristics of Trial Participants (Per-Protocol Analysis)
| Characteristic | Overall (N = 97)a | Intervention Group (n = 46)a | Control Group (n = 51)a | P Value |
|---|---|---|---|---|
| Age, y, mean (SD) | 59.5 (11.2) | 59.8 (10.8) | 59.3 (11.7) | .811 |
| Sex, No. (%) | .022 | |||
| Male | 39 (40.2) | 24 (52.2) | 15 (29.4) | |
| Female | 58 (59.8) | 22 (47.8) | 36 (70.6) | |
| Ethnicity, No. (%) | .440 | |||
| Malay | 88 (90.7) | 43 (93.5) | 45 (88.2) | |
| Indian | 6 (6.2) | 2 (4.3) | 4 (7.8) | |
| Chinese | 1 (1.0) | 1 (2.2) | 0 (0) | |
| Other | 2 (2.1) | 0 (0) | 2 (3.9) | |
| Education level, No. (%) | .282 | |||
| No formal education | 4 (4.1) | 1 (2.2) | 3 (5.9) | |
| Elementary | 29 (29.9) | 13 (28.3) | 16 (31.4) | |
| High school | 43 (44.3) | 20 (43.5) | 23 (45.1) | |
| College/university | 21 (21.6) | 12 (26.1) | 9 (17.6) | |
| Days fasted during Ramadan, median (IQR) | 30 (26-30) | 30 (27-30) | 30 (26-30) | .896 |
| Duration of diabetes, y, median (IQR) | 10 (5.0-20.0) | 10 (5.0-15.0) | 11 (4.5-21.5) | .529 |
| Number of comorbidities, mean (SD) | 3.75 (1.24) | 3.72 (1.24) | 3.78 (1.25) | .793 |
| Diabetes regimen, No. (%) | .084 | |||
| Insulin only | 2 (2.1) | 2 (4.3) | 0 (0) | |
| Oral therapy only | 59 (60.8) | 31 (67.4) | 28 (54.9) | |
| Insulin and oral therapy | 36 (37.1) | 13 (28.3) | 23 (45.1) | |
| BMI, kg/m2, mean (SD) | 30.3 (5.5) | 29.7 (5.6) | 30.8 (5.4) | .352 |
| HbA1c, mean (SD) | .932 | |||
| % | 7.8 (0.9) | 7.8 (0.9) | 7.8 (0.9) | |
| mmol/mol | 62 (9.9) | 62 (9.9) | 62 (9.9) | |
| Fasting blood glucose, mg/dL, mean (SD) | 120.8 (28.9) | 123.7 (27.1) | 118.6 (32.5) | .283 |
| Postprandial glucose, mg/dL, mean (SD) | 196.4 (55.9) | 191.0 (41.5) | 201.8 (68.5) | .867 |
| Creatinine clearance, mL/min, mean (SD) | 60.3 (29.6) | 58.8 (30.1) | 61.7 (29.4) | .635 |
BMI = body mass index; HbA1c = glycated hemoglobin; IQR = interquartile range.
↵a Data are presented as number (%) for categoric variables, mean (SD) for normally distributed continuous variables, and median (IQR) for nonnormally distributed continuous variables.