Table 2.
Outcomes at 12 weeks by modified intention to treat analysis
| LEI (n = 45) | LEI + MR (n = 48) | p-value between groups | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 12 weeks | Changes | p-value | Baseline | 12 weeks | Changes | p-value | ||
| Anthropometric changes | |||||||||
| Body weight, kg | 84.4 (75.6, 105) | 81.5 (74.6, 104.8) | −1.4 (−2.75, 0) | 0.01 | 82.8 (72.9, 94.1) | 80.3 (69.8, 90.6) | −2.3 (−4.93, −0.68) | <0.01 | 0.01 |
| Body mass index, kg/m2 | 33.1 (29.8, 38.3) | 32.6 (28.9, 37.7) | −0.49 (−1.0, −0.00) | <0.01 | 31.9 (30.4, 36.1) | 30.6 (28.6, 35.4) | −0.94 (−1.77, −0.3) | <0.01 | 0.01 |
| Weight loss, % | 1.53 (−0.01, 3.05) | 2.86 (1.07, 5.7) | 0.01 | ||||||
| Waist circumference, cm | 101 (97, 115.3) | 99 (94.3, 115.3) | −2.5 (−5.5, 0.25) | <0.01 | 103.3 (96.6, 111.8) | 99 (92.3, 108.5) | −3.25 (−6.0, −1.13) | <0.01 | 0.13 |
| Fat mass, % | 38.6 ± 1a | 37 ± 1.0a | −0.8 (−2.2, 0.05) | <0.01 | 38.9 ± 1a | 37.8 ± 0.9a | −1 (−1.7, −0.03) | <0.01 | 0.83 |
| Fat mass, kg | 32 (26.1, 42.7) | 30.9 (23.4, 40.9) | −1.05 (−2.62, −0.19) | <0.01 | 29.8 (26.7, 39.9) | 28.2 (24.9, 38.7) | −1.58 (−3.52, −0.57) | <0.01 | 0.20 |
| Fat-free mass, kg | 52.5 (46.2, 60.5) | 51.7 (46.2, 60.1) | 0.23 (−1.16, 1.31) | 0.46 | 49.1 (45.6, 56.9) | 48.6 (44.5, 56.6) | −1.01 (−1.85, 0.61) | 0.02 | 0.02 |
| Fat mass index, kg/m2 | 13 (10.4, 15.2) | 12.6 (9.5, 14.1) | −0.44 (−0.98, −0.07) | <0.01 | 11.9 (10.9, 14.9) | 11.5 (9.8, 14.3) | −0.59 (−1.29, −0.24) | <0.01 | 0.21 |
| Fat-free mass index, kg/m2 | 20.4 (18.5, 22.9) | 20.7 (18.4, 22.8) | 0.09 (−0.46, 0.5) | 0.47 | 19.9 (18.5, 21.8) | 19.7 (18.3, 21.1) | −0.39 (−0.77, 0.24) | 0.02 | 0.02 |
| Metabolic and cardiovascular indices | |||||||||
| Systolic blood pressure, mmHg | 129 (117, 141) | 124.9 ± 1.9a | −5.11 ± 2.06a | 0.02 | 129 (114, 141) | 122.5 ± 2.3a | −5 ± 2.22a | 0.03 | 0.97 |
| Diastolic blood pressure, mmHg | 75 (71, 84) | 73.8 ± 1.7a | −4.53 ± 1.6a | 0.01 | 77 (68, 85) | 71.1 ± 1.5a | −5.65 ± 1.59a | <0.01 | 0.62 |
| Pulse rate, bpm | 77 (72, 85) | 75 (70, 84) | −3.0 (−9.0, 5.5) | 0.49 | 77 (72, 85) | 75 (68, 82) | −1.5 (−10, 4) | 0.03 | 0.68 |
| Fasting plasma glucose, mmol/L | 5.55 (5.16, 6.11) | 5.61 (5.08, 5.97) | 0.00 (−0.25, 0.19) | 0.54 | 5.77 (5.34, 6.22) | 5.44 (5.11, 5.81) | −0.22 (−0.56, 0.06) | <0.01 | 0.03 |
| Fasting insulin, pmol/L | 131.6 (76.1, 217.9) | 146.6 (100, 212.2) | 18.1 (−27.4, 51.8) | 0.10 | 123.6 (70.5, 181.2) | 97.9 (70.7, 160.3) | −14.2 (−51.2, 30.8) | 0.22 | 0.03 |
| HOMA-IR | 4.49 (2.41, 7.83) | 4.59 (3.47, 7.3) | 0.55 (−0.83, 1.76) | 0.14 | 4.7 (2.5, 6.67) | 3.27 (2.42, 6) | −0.7 (−2.41, 1.09) | 0.22 | 0.02 |
| Haemoglobin A1c, mmol/mol | 40.1 ± 0.7a | 41 (37.7, 44.3) | 1.09 (−0.55, 2.19) | 0.03 | 41.2 ± 0.7a | 39.9 (37.7, 43.2) | 0.00 (−2.19, 1.09) | 0.30 | 0.01 |
| Total cholesterol, mmol/L | 5.04 ± 0.15a | 4.99 ± 0.13a | −0.13 (−0.36, 0.19) | 0.55 | 5.18 ± 0.14a | 4.99 ± 0.13a | −0.2 (−0.52, 0.21) | 0.05 | 0.31 |
| Triglyceride, mmol/L | 1.53 (1.15, 2.1) | 1.39 (1.15, 1.92) | 0.00 (−0.38, 0.26) | 0.21 | 1.7 (1.29, 2.15) | 1.55 (1.1, 2.22) | −0.12 (−0.27, 0.08) | 0.45 | 0.46 |
| HDL-c, mmol/L | 1.14 (1.01, 1.27) | 1.11 (0.96, 1.3) | −0.03 (−0.12, 0.08) | 0.35 | 1.18 (1.04, 1.45) | 1.15 (1.02, 1.37) | −0.01 (−0.13, 0.08) | 0.96 | 0.96 |
| LDL-c, mmol/L | 3.09 ± 0.13a | 3.12 ± 0.11a | 0.08 (−0.27, 0.35) | 0.70 | 3.13 ± 0.15a | 2.96 ± 0.13a | −0.23 (−0.43, 0.21) | 0.08 | 0.07 |
| Microalbuminuria, mg/g Cr | 7.9 (4.55, 24.2) | 5.8 (3.4, 23.4) | −1.1 (−6.55, 1.85) | 0.34 | 10.35 (4.18, 21.08) | 8.05 (4.75, 15.73) | −0.55 (−7.23, 2.78) | 0.69 | 0.59 |
Numbers are median (P25, P75)
Fat mass index computed by Fat mass (kg)/ height (m)2, Fat-free mass index computed by fat-free mass (kg)/ height (m)2, HOMA-IR homeostatic model assessment of insulin resistance, HDL-c high-density lipoprotein cholesterol, LDL-c low-density lipoprotein cholesterol, Cr creatinine
aNumbers are means ± SE