Table 4.
Mean change in metabolic markers after 6 months (ITT).
| AGE-Lowering Arm (n = 33) | SOC Arm (n = 37) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Follow-Up | Delta | p 1 | Baseline | Follow-Up | Delta | p 1 | p 2 | |
| Insulin (mU/L) | 14.74 ± 10.86 | 12.44 ± 8.96 | (n = 25) * | 0.10 | 14.05 ± 5.90 | 11.61 ± 5.09 | (n = 27) * | 0.04 | 0.90 |
| 2.28 ± 6.87 | −2.09 ± 4.43 | ||||||||
| HbA1C% | 6.61 ± 0.68 | 6.58 ± 0.81 | −0.03 ± 0.46 | 0.20 | 6.72 ± 0.66 | 6.71 ± 0.61 | −0.01 ± 0.51 | 0.78 | 0.84 |
| Glucose (mg/dL) | 131.12 ± 23.31 | 125.06 ± 21.49 | −6.06 ± 23.75 | 0.15 | 126.97 ± 33.90 | 121.54 ± 22.75 | −5.43 ± 27.53 | 0.23 | 0.91 |
| HOMA-IR | 4.90 ± 4.14 | 3.97 ± 3.32 | (n = 25) * | 0.08 | 4.42 ± 1.9 | 3.44 ± 1.47 | (n = 27) * | 0.02 | 0.87 |
| −0.94 ± 2.55 | −0.872 ± 1.74 | ||||||||
| Creatinine Clearance (mL/min) | 85.52 ± 26.93 | 84.08 ± 25.06 | −1.18 ± 13.31 | 0.61 | 88.23 ± 18.52 | 85.55 ± 18.78 | −2.17 ± 7.76 | 0.10 | 0.70 |
| BMI (kg/m2) | 30.05 ± 4.30 | 29.54 ± 4.25 | −0.50 ± 1.11 | 0.02 | 29.36 ± 3.63 | 28.93 ± 3.77 | −0.42 ± 1.38 | 0.05 | 0.94 |
| Waist (cm) | 107.03 ± 10.62 | 106.13 ± 9.08 | −0.89 ± 5.31 | 0.17 | 105.70 ± 10.97 | 105.16 ± 11.27 | −0.83 ± 5.42 | 0.22 | 0.74 |
| Physical activity (METs/day) | 150.53 ± 131.83 | 143.13 ± 107.75 | −7.39 ± 94.96 | 0.62 | 118.43 ± 117.72 | 153.31 ± 139.57 | 34.88 ± 132.62 | 0.12 | 0.12 |
All values expressed as mean ± SD. Abbreviations and explanation: ITT: Intention to treat analysis; AGEs: Advanced glycation end products; SOC; Standard of care; HbA1C: glycated hemoglobin HOMA-IR: Homeostatic model assessment of insulin resistance; BMI: Body max index. * Insulin and HOMA-IR include only participants who do not use insulin. p 1 change between baseline and 6 months visit within arm; p 2 difference in mean change between AGE-lowering vs. SOC arms.