Study metabolic variables
| Baseline | Week 2 | Month 3 | Month 6 | Month 9 | Month 12 | Δ, 0–12 months p Value | |
| Weight | |||||||
| BMI (kg/m2) | 34.1 (3.51) | 32.7 (3.52) | 31.8 (3.31) | 30.9 (3.27) | 30.9 (2.99) | 30.6 (3.39) | <0.01 |
| Weight (kg) | 104.3 (17.34) | 99.8 (16.88) | 97.1 (15.24) | 94.3 (14.96) | 94.5 (14.82) | 93.4 (16.04) | <0.01 |
| Weight loss (%) | NA | 4.2 (1.92) | 6.6 (2.80) | 9.4 (3.91) | 9.1 (4.64) | 10.3 (5.79) | <0.01 |
| Waist circumference (cm) | 121.5 (16.19) | 113.9 (10.56) | 115.4 (20.23) | 109.2 (10.55) | 109.0 (10.26) | 107.2 (10.23) | <0.01 |
| Blood pressure | |||||||
| Systolic blood pressure (mm Hg) | 139.9 (9.97) | 125.6 (14.44) | 125.2 (19.18) | 125.4 (10.60) | 124.9 (11.12) | 124.5 (11.51) | <0.01 |
| Diastolic blood pressure (mm Hg) | 87.1 (7.07) | 81.8 (10.20) | 81.5 (11.68) | 81.9 (7.26) | 80.9 (5.55) | 85.6 (6.78) | 0.59 |
| Glycemic end points | |||||||
| HbA1c (%) | 9.4 (0.87) | 8.6 (0.72) | 7.9 (1.04) | 7.8 (1.66) | 7.5 (1.24) | 7.1 (1.12) | <0.01 |
| Fasting blood glucose (mg/dL) | 233.2 (42.54) | 174.0 (40.50) | 165.3 (48.87) | 169.9 (83.83) | 116.9 (26.61) | 141.5 (29.80) | <0.01 |
| Fasting C peptide (ng/mL) | 3.3 (1.87) | 3.7 (1.89) | 2.6 (0.99) | 2.9 (1.12) | 2.4 (0.98) | 2.4 (1.16) | 0.10 |
| Fasting insulin (U/mL) | 21.1 (17.43) | 15.9 (11.37) | 11.1 (6.34) | 11.9 (6.19) | 10.1 (5.11) | 9.6 (6.53) | 0.01 |
| Serum lipids | |||||||
| HDL-C (mg/dL) | 38.3 (7.94) | 32.0 (6.40) | 33.4 (7.96) | 35.4 (6.73) | 35.2 (6.52) | 36.9 (8.60) | 0.35 |
| LDL-C (mg/dL) | 103.3 (27.71) | 82.1 (32.95) | 75.0 (28.84) | 77.4 (30.72) | 67.3 (24.30) | 79.0 (30.54) | 0.03 |
| Triglycerides (mg/dL) | 159.3 (97.35) | 132.8 (106.20) | 115.1 (123.90) | 141.6 (159.30) | 106.2 (159.30) | 123.9 (106.20) | 0.03 |
| Liver function | |||||||
| ALT (U/L) | 64.4 (32.87) | 52.5 (26.06) | 44.2 (21.05) | 45.2 (20.34) | 48.1 (19.92) | 43.6 (16.54) | 0.02 |
| AST (U/L) | 42.0 (21.28) | 33.5 (14.88) | 35.8 (16.22) | 32.4 (12.08) | 31.9 (11.14) | 29.0 (11.79) | 0.02 |
| GGT (U/L) | 85.2 (74.79) | 67.5 (45.60) | 44.8 (28.42) | 41.0 (24.17) | 43.2 (31.95) | 40.3 (37.38) | 0.01 |
| Serum albumin (g/dL) | 4.5 (0.15) | 4.4 (0.27) | 4.3 (0.61) | 4.4 (0.34) | 4.3 (0.60) | 4.3 (0.83) | 0.37 |
| Renal function | |||||||
| Creatinine (mg/dL) | 0.79 (0.126) | 0.89 (0.149) | 0.81 (0.116) | 0.81 (0.141) | 0.81 (0.150) | 0.77 (0.129) | 0.51 |
| BUN (mg/dL) | 13.8 (3.18) | 12.8 (2.14) | 13.8 (4.67) | 13.2 (3.34) | 13.6 (2.41) | 16.1 (3.87) | 0.03 |
| Vitamin level | |||||||
| Vitamin B-12 (pg/mL) | 343.9 (147.37) | – | – | – | – | 223.6 (112.80) | <0.01 |
| OGTT testing | |||||||
| Blood glucose AUC (mg/dL·hour) | 1467 (153.8) | – | 1130 (296.0) | – | – | 902 (244.6) | <0.01 |
| Insulin sensitivity (Matusda Index15) | 1.1 (0.50) | – | 3.9 (7.91) | – | – | 4.3 (5.92) | 0.06 |
| Β-cell function (pmol/mmol) | 85.8 (40.90) | – | 106.4 (55.35) | – | – | 133.5 (45.79) | <0.01 |
| GLP-1 AUC (pM·hour) | 37.9 (26.32) | – | 72.6 (56.38) | – | – | 73.4 (63.56) | 0.01 |
Data are mean (SD). For triglycerides, median and IQR are presented.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; AUC, area under curve; BMI, body mass index; BUN, blood urea nitrogen; GGT, gamma-glutamyl transferase; HbA1c, hemoglobin A1c; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; OGTT, oral glucose tolerance testing.