Prospective Study
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©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Jan 15, 2025; 16(1): 98322
Published online Jan 15, 2025. doi: 10.4239/wjd.v16.i1.98322
Table 1 Baseline demographic and clinical characteristics of the patients, n (%)
Group A (1 + 2) (n = 51) Group B (2 + 3) (n = 81) All patients (n = 132) P valueAge (years) 54.4 ± 10.3 56.7 ± 9.6 55.8 ± 9.8 0.068 Gender Female 14 (27.5) 41 (50.6) 55 (41.7) 0.009a Male 37 (72.5) 40 (49.4) 77 (58.3) Education 0.141 No literacy 2 (3.9) 12 (14.8) 14 (10.6) Primary school 27 (52.9) 43 (53.1) 70 (53.0) Middle school 9 (17.6) 6 (7.4) 15 (11.4) High school 9 (17.6) 16 (19.8) 25 (18.9) Higher education 4 (7.8) 4 (4.9) 8 (6.1) Physical activity 0.088 Inactive 24 (47.1) 48 (59.3) 72 (54.5) Moderately inactive 18 (35.3) 19 (23.5) 37 (28) Moderately active 9 (17.6) 9 (11.1) 18 (13.6) Active 0 (0) 5 (6.2) 5 (3.8) Diabetes course Newly diagnosed T2DM 23 (45.1) 0 (0) 23 (17.4) Patients with previously controlled T2DM 28 (54.9) 0 (0) 28 (21.2) T2DM patients whose HBA1c were previously not on target but now worsened 0 (0) 32 (39.5) 32 (24.2) T2DM patients whose HbA1c were ≥ 10% for a long time 0 (0) 49 (60.5) 49 (37.2) Weight (kg) 83 (21) 81 ± 14 81 (19) 0.350 BMI (kg/m2 ) 29.4 ± 3.5 29.5 ± 4.8 29.5 ± 4.3 0.821 Waist circumference (cm) 102.1 ± 12.8 101.8 ± 14.3 101.9 ± 13.7 0.917 Duration of diabetes (year) 4 (12) 10 (8) 10 (10) 0.000a CKD 4 (8) 4 (5) 8 (6) 0.710 Mindful eating 3.3 ± 0.6 3.4 ± 0.6 3.4 ± 0.6 0.324 BDI 7.9 ± 5.9 12 (12) 10 (9) 0.000a Glucose (mg/dL) 283.9 ± 75.9 238.7 ± 77.4 254.3 ± 79.4 0.007a LDL-C (mg/dL) 101 ± 41.9 106 (53) 100 (53) 0.989 HDL-C (mg/dL) 36 (22) 43.6 ± 11.3 42 (18) 0.048a Triglyceride (mg/dL) 203.7 ± 136.7 189.1 ± 27.12 195.3 ± 96.7 0.692 Total cholesterol (mg/dL) 177 (67) 188 (49) 184 (54) 0.905 C-peptide (ng/mL) 3.1 ± 1.6 2.6 ± 1.2 2.5 (1.7) 0.060 Urea (mg/dL) 27 (10) 31.6 ± 7.9 31.2 ± 9.7 0.137 Creatinine (mg/dL) 0.8 (0.2) 0.7 ± 0.2 0.8 (0.3) 0.323 HbA1c (%) 12.9 ± 2.5 11 (2.9) 11.2 (3.2) 0.054
Table 2 Baseline clinical outcomes for each group, mean ± SD, n (%)
Group 1 (n = 23) Group 2 (n = 28) Group 3 (n = 32) Group 4 (n = 49) P valueWeight (kg) 84.5 ± 20.1 86 ± 16.8 80.4 ± 13.7 81.6 ± 14.9 0.4471 BMI (kg/m2 ) 28.8 ± 4.3 31.1 ± 4.8 29.1 ± 5.1 30.3 ± 4.9 0.2741 Waist circumference (cm) 98 (16) 102.1 ± 10.4 100 (11) 104.3 ± 12.3 0.5402 Glucose (mg/dL) 294.1 ± 87.8 276.1 ± 76.3 229.1 ± 72.8 257.2 ± 76.7 0.016a , 1 LDL-C (mg/dL) 110 ± 38.3 114.5 (77) 106.7 ± 33.3 115.9 ± 38.3 0.8242 HDL-C (mg/dL) 42.6 (13.4) 39.2 ± 12.8 43.2 ± 10.9 45.3 (12.5) 0.1942 Triglyceride (mg/dL) 237 ± 122.2 244.5 (166.3) 173 ± 126 268.8 ± 259.2 0.7222 Total cholesterol (mg/dL) 200.1 (43.2) 208.2 ± 72.8 195.4 ± 46.6 208.7 ± 43 0.5932 C-peptide (ng/mL) 2.8 ± 1.1 3.2 ± 1.6 2.8 ± 1.4 2.4 ± 1 0.0681 HbA1c (%) 13.4 ± 1.9 11.3 (2.4) 11.5 (2.9) 11.1 (2.3) 0.007a , 2
Table 3 Clinical outcomes after 12 months for group a and group B, mean ± SD, n (%)
Group A (1 + 2) (n = 51) Group B (2 + 3) (n = 81) All patients (n = 132) P valueWeight (kg) 84 ± 14 80 ± 14 82 ± 14 0.159 BMI (kg/m2 ) 30 ± 4.5 30.4 ± 5.2 30.2 ± 4.9 0.942 Waist circumference (cm) 102.5 ± 12.4 102.7 ± 14 102 (16) 0.741 Glucose (mg/dL) 133.5 (36.8) 172.9 ± 57.5 145 (77) 0.000a LDL-C (mg/dL) 86.1 ± 33.6 95.7 ± 36.8 91.9 ± 35.7 0.335 HDL-C (mg/dL) 46.1 ± 15.1 45 ± 9.5 45.4 ± 11.9 0.390 Triglyceride (mg/dL) 153 (123.8) 155 ± 87 155 (100) 0.566 Total cholesterol (mg/dL) 166.9 ± 39.7 173.2 ± 42.9 170.7 ± 41.5 0.382 C-peptide (ng/mL) 2.7 (2) 2.1 (1.9) 2.3 (1.8) 0.012a HbA1c (%) 7 (1.2) 8.5 (2) 7.8 (2.1) 0.000a
Table 4 Clinical outcomes after 12 months for each group, mean ± SD, n (%)
Group 1 (n = 23) Group 2 (n = 28) Group 3 (n = 32) Group 4 (n = 49) P valueWeight (kg) 80.8 ± 14.3 86.5 ± 13.8 80.9 ± 13.5 79.8 ± 14.3 0.2531 BMI (kg/m2 ) 28.3 ± 3.4 31 ± 4.9 29.3 ± 5.3 30.1 ± 4.7 0.2201 Waist circumference (cm) 101.9 ± 14.4 103.8 ± 10.9 100.7 ± 15 103 ± 14.2 0.8441 Glucose (mg/dL) 125 ± 32.2 154.7 ± 45.6 137.5 (59) 199 (113) 0.000a , 2 LDL-C (mg/dL) 86.3 ± 31.2 93.1 ± 39.1 97.6 ± 36.7 95.8 ± 41.2 0.7241 HDL-C (mg/dL) 51 ± 26 45.6 ± 13.4 44.7 ± 11 45.7 ± 14.6 0.5091 Triglyceride (mg/dL) 158 ± 89.8 186.5 (108.5) 149 (97) 165 (105) 0.1202 Total cholesterol (mg/dL) 164 ± 30.7 180 ± 51.7 178.1 ± 44.5 170 (63) 0.5282 C-peptide (ng/mL) 2.4 (2.1) 3.3 ± 1.4 2.5 ± 1.4 2.1 (1.1) 0.0812 HbA1c (%) 6.6 ± 0.9 7.7 ± 1.3 8.4 ± 1.7 9.4 ± 2 0.000a , 1
Table 5 Comparison of clinical outcomes at baseline and 12 months for group A and group B
Group A differences (n = 51) P valueCohen’s d effect size Group B difference (n = 81) P valueCohen’s d effect size All patients difference (n = 132) P valueCohen’s d effect size Weight (kg) -1.5 0.2822 0.1 -0.9 0.3571 0.1 -1.0 0.0642 0.1 BMI (kg/m2 ) -0.7 0.3292 0.1 0.0 0.9851 0.0 -0.1 0.8281 0.0 Waist circumference (cm) 2.5 0.8372 0.1 0.5 0.5072 0.0 1.5 0.5272 0.0 Glucose (mg/dL) -144.0 0.000a , 2 2.2 -72.5 0.000a , 2 0.6 -113.0 0.000a , 2 1.1 LDL-C (mg/dL) -26.0 0.015a , 2 0.6 -15.8 0.040a , 1 0.4 -16.0 0.001a , 2 0.5 HDL-C (mg/dL) 6.0 0.000a , 2 0.4 1.0 0.7332 0.1 2.0 0.002a , 2 0.2 Triglyceride (mg/dL) -38.0 0.003a , 2 0.4 -26.0 0.000a , 2 0.3 -33.0 0.000a , 2 0.3 Total cholesterol (mg/dL) -25.0 0.001a , 2 0.6 -20.0 0.000a , 2 0.5 -22.5 0.000a , 2 0.5 C-peptide (ng/mL) 0.2 0.9502 0.1 -0.1 0.2992 0.1 -0.1 0.417 0.0 HbA1c (%) -5.1 0.000a , 2 3.2 -2.5 0.000a , 2 1.6 -3.9 0.000a , 2 2.1
Table 6 Comparison of clinical outcomes at baseline and 12 months for each group
Group 1 differences (n = 23) P valueCohen’s d effect size Group 2 differences (n = 28) P valueCohen’s d effect size Group 3 differences (n = 32) P valueCohen’s d effect size Group 4 differences (n = 49) P valueCohen’s d effect size Weight (kg) -3.7 0.4761 0.2 0.5 0.2732 0.0 0.5 0.5622 0.0 -1.8 0.1202 0.1 BMI (kg/m2 ) -0.5 0.4361 0.1 -0.1 0.8621 0.0 0.2 0.5441 0.0 -0.2 0.4691 0.0 Waist circumference (cm) 2.5 0.9842 0.0 1.7 0.9501 0.2 -1.0 0.6652 0.2 -1.3 0.6621 0.1 Glucose (mg/dL) -169.1 0.000a , 1 2.6 -121.4 0.000a , 1 1.9 -80.5 0.000 a , 2 1.1 -47.5 0.003a , 2 0.5 LDL-C (mg/dL) -23.7 0.029a , 1 0.7 -28.5 0.0951 0.5 -9.1 0.1351 0.3 -20.1 0.1471 0.5 HDL-C (mg/dL) 6.0 0.026a , 2 0.4 6.4 0.000a , 1 0.5 1.5 0.3311 0.1 -2.0 0.6592 0.0 Triglyceride (mg/dL) -79 0.000a , 1 0.7 -15.0 0.4382 0.2 -24.0 0.006a , 2 0.3 -29.0 0.006a , 2 0.4 Total cholesterol (mg/dL) -24. 0.002a , 2 1.0 -28.2 0.041a , 1 0.4 -17.3 0.011a , 1 0.4 -26.0 0.005a , 2 0.6 C-peptide (ng/mL) 0.0 0.7842 0.3 0.1 0.9271 0.1 -0.3 0.1441 0.2 -0.1 0.6922 0.0 HbA1c (%) -6.8 0.000a , 1 4.5 -3.8 0.000 a , 2 2.6 -3.6 0.000a , 2 2.2 -1.7 0.000a , 2 1.3
Table 7 Demographic and clinical characteristics by glycated hemoglobin levels (< 7% vs ≥ 7%) at 12 months, mean ± SD, n (%)
HbA1c ≤ 7% (n = 38) HbA1c > 7% (n = 94) P valueAge (years) 54.2 ± 10.2 55.8 ± 10.5 0.326 Gender 0.135 Female 12 (32) 43 (46) Male 26 (68) 51 (54) Education No literacy 3 (7.9) 11 (12) 0.709 Primary school 18 (47) 52 (55) Middle school 6 (16) 9 (9.6) High school 8 (21) 17 (18) Higher education 3 (7.9) 5 (5.3) Physical activity Inactive 20 (56) 43 (49) 0.554 Moderately inactive 8 (22) 29 (33) Moderately active 7 (19) 11 (13) Active 1 (2.8) 4 (4.6) Diabetes course Newly diagnosed T2DM 15 (39) 8 (8.5) 0.000a Patients with previously controlled T2DM 11 (29) 17 (18) T2DM patients whose HBA1c were previously not on target but now worsened 7 (18) 25 (27) T2DM patients whose HbA1c were ≥ 10% for a long time 5 (13) 44 (47) Weight (kg) 83.9 ± 12.8 80.7 ± 14.5 0.215 BMI (kg/m2 ) 29.7 ± 3.8 29.8 ± 5.1 0.848 Waist circumference (cm) 102.8 ± 12.6 102.3 ± 14.2 0.787 Duration of diabetes (year) 5.4 ± 5.9 10.7 ± 6.9 0.000a Mindful eating 3.3 ± 0.6 3.4 ± 0.5 0.320 BDI 8.6 ± 5.5 12.6 ± 8.5 0.022a Glucose (mg/dL) 116.9 ± 20.8 195.5 ± 85.7 0.000a LDL-C (mg/dL) 82.1 ± 33.3 98.9 ± 38.6 0.074 HDL-C (mg/dL) 45.3 ± 22.0 46.8 ± 13.2 0.062 Triglyceride (mg/dL) 169.5 ± 92.9 198.0 ± 144.2 0.470 Total cholesterol (mg/dL) 159.4 ± 33.7 184.6 ± 50.6 0.029a C-peptide (ng/mL) 3.3 ± 1.6 2.5 ± 1.2 0.006a HbA1c (%) 6.4 ± 0.5 9.1 ± 1.7 0.000a
Table 8 Medication utilization after 12 months: Group A vs group B, n (%)
Medication Usage Group A Group B All patients P valueMTF Yes 40 (78.4) 64 (79) 104 (78.8) 0.937 No 11 (21.6) 17 (21) 28 (21.2) DPP-IV Yes 27 (52.9) 63 (77.8) 90 (68.2) 0.003a No 24 (47.1) 18 (22.2) 42 (31.8) SGLT2 Yes 37 (72.5) 64 (79) 101 (76.5) 0.394 No 14 (27.5) 17 (21) 31 (23.5) Pioglitazone Yes 19 (37.3) 33 (40.7) 52 (39.4) 0.690 No 32 (62.7) 48 (59.3) 80 (60.6) Basal insulin Yes 4 (7.8) 33 (40.7) 37 (28) 0.000a No 47 (92.2) 48 (59.3) 95 (72) Basal-bolus insulin Yes 4 (7.8) 15 (18.5) 19 (14.4) 0.089 No 47 (92.2) 66 (81.5) 113 (85.6) Mixed insulin Yes 2 (3.9) 12 (14.8) 14 (10.6) 0.048a No 49 (96.1) 69 (85.2) 118 (89.4)
Table 9 Medication utilization after 12 months: Glycated hemoglobin ≤ 7% vs glycated hemoglobin > 7%, n (%)
Medication Usage HbA1c ≤ 7% HbA1c > 7% P valueMTF Yes 34 (89.5) 70 (74.5) 0.046a No 4 (10.5) 24 (25.5) DPP-IV Yes 24 (63.2) 66 (70.2) 0.431 No 14 (36.8) 28 (29.8) SGLT2 Yes 29 (76.3) 72 (76.6) 0.973 No 9 (23.7) 22 (23.4) Pioglitazone Yes 16 (42.1) 36 (38.3) 0.685 No 22 (57.9) 58 (61.7) Basal insulin Yes 4 (10.5) 33 (35.1) 0.004a No 34 (89.5) 61 (64.9) Basal-bolus insulin Yes 1 (2.6) 18 (19.1) 0.014a No 37 (97.4) 76 (80.9) Mixed insulin Yes 0 (0) 14 (14.9) 0.012a No 38 (100) 80 (85.1)