Table 2.
Baseline Values of Primary and Secondary Outcome Data by Treatment Group
| Treatment Arm | ||||
|---|---|---|---|---|
| Characteristic | Arm A (N = 105) | Arm B (N = 84) | Arm C (N = 82) |
Arm D (N = 106) |
| Insulin, n | 102 | 81 | 78 | 100 |
| Median (IQR), pmol/L | 54 (35–90) | 57 (37–87) | 61 (40–85) | 51 (36.5–75.5) |
| [min–max], pmol/L | [11–279] | [21–319] | [21–432] | [21–454] |
| Glucose, n | 104 | 83 | 80 | 104 |
| Mean (SD), mmol/L | 5.2 (0.5) | 5.2 (0.58) | 5.29 (0.7) | 5.22 (0.54) |
| [min–max], mmol/L | [4.2–6.9] | [4.0–7.6] | [3.2–8.5] | [4.1–6.8] |
| NEFA, n | 104 | 82 | 79 | 102 |
| Median (IQR), mmol/L | 0.42 (0.27–0.615) | 0.385 (0.25–0.58) | 0.35 (0.25–0.55) | 0.40 (0.30–0.59) |
| [min–max], mmol/L | [0.08–1.21) | [0.07–1.08] | [0.05–0.84] | [0.08–1.21] |
| HOMA-IR, n | 100 | 81 | 78 | 100 |
| Median (IQR) | 1.808 (1.120–2.903) | 1.860 (1.208–3.508) | 2.117 (1.223–3.297) | 1.628 (1.175–.490) |
| [min–max] | [0.408–10.775] | [0.578–9.800] | [0.618–17.495] | [0.591–16.852] |
| QUICKI, n | 100 | 81 | 78 | 100 |
| Mean (SD) | 0.117 (0.009) | 0.116 (0.009) | 0.116 (0.010) | 0.118 (0.009) |
| [min–max] | [0.097–0.142] | [0.098–0.135] | [0.093–0.134] | [0.093–0.135] |
| Revised QUICKI, n | 100 | 81 | 78 | 99 |
| Mean (SD) | 0.132 (0.017) | 0.134 (0.019) | 0.134 (0.019) | 0.133 (0.016) |
| [min–max] | [0.101–0.184] | [0.100–0.211] | [0.100–0.212] | [0.096–0.178] |
| HDLc, n | 104 | 82 | 79 | 103 |
| Median (IQR), mmol/L | 1.15 (0.9–1.4) | 1.1 (1.0–1.4) | (0.9–1.4) | (1.0–1.4) |
| [min–max], mmol/L | [0.5–3.0] | [0.3–2.7] | [0.2–2.8] | [0.5–2.9] |
| Cholesterol, n | 104 | 82 | 79 | 103 |
| Mean (SD), mmol/L | 5.01 (0.99) | 5.0 (1.11) | 4.83 (1.04) | 4.97 (1.04) |
| [min–max], mmol/L | [2.2–8.2] | [2.6–8.3] | [2.5–7.1] | [2.9–7.64] |
| Triglycerides, n | 104 | 82 | 79 | 103 |
| Median (IQR), mmol/L | 1.4 (1.0–2.0) | 1.25 (0.9–1.8) | 1.4 (1.0–1.9) | 1.2 (0.9–1.8) |
| [min–max], mmol/L | [0.5–6.5] | [0.4–4.8] | [0.5–6.1] | [0.4–6.7] |
| LDLc, n | 103 | 81 | 78 | 102 |
| Mean (SD), mmol/L | 3.1 (0.91) | 3.14 (0.97) | 2.97 (0.9) | 3.12 (0.91) |
| [min–max], mmol/L | [1.1–6.4] | [1.1–6.2] | [0.8–5.2] | [0.8–5.6] |
| Adiponectin, n | 104 | 82 | 78 | 101 |
| Median (IQR), µg/mL | 14.62 (10.11–20.50) | 16.27 (12.05–21.84) | 13.69 (9.22–20.31) | 13.47 (8.28–18.51) |
| [min–max], µg/mL | [3.14–44.34] | [1.73–60.49] | [2.01–66.19] | [2.74–129.01] |
| Leptin, n | 104 | 81 | 78 | 103 |
| Median (IQR), pg/mL | 4856.7 (1885.9–13 879) | 4688.7 (2149–15 786) | 5227.2 (2271.4–9710) | 4492.2 (2126.5–10 192) |
| [min–max], pg/mL | [253.64–123 299] | [388.38–192 842] | [168.11–119 430] | [502.59–104 002] |
| IL-8, n | 104 | 82 | 78 | 102 |
| Median (IQR), pg/mL | 17 (12.98–22.7) | 14.38 (11.65–18.67) | 16.32 (11.83–25.12) | 18.57 (12.75–29.53) |
| [min–max], pg/mL | [5.67–744.98] | [5.18–166.7] | [6.04–187.86] | [4.51–368.69] |
| TNF-ɑ, n | 103 | 82 | 78 | 101 |
| Median (IQR), pg/mL | 2.31 (1.69–3.49) | 2.1 (1.74–2.49) | 2.39 (1.71–2.99) | 2.35 (1.77–3.09) |
| [min–max], pg/mL | [0.58–12.61] | [1.04–6.27] | [0.49–8.11] | [0.85–56.89] |
| Resistin, n | 104 | 82 | 78 | 101 |
| Median (IQR), pg/mL | 5602.7 (3936.6–7998.5) | 4790.2 (3713.7–6966.3) | 5114 (3656.4–6861) | 5684.9 (4590.9–8367.2) |
| [min–max], pg/mL | [1667.2–30 299] | [1288.2–20 357] | [1180–13 781] | [1607.7–19 692] |
| hs-CRP, n | 104 | 82 | 78 | 103 |
| Median (IQR), mg/L | 2.24 (1.03–4.04) | 1.4 (0.71–3.93) | 1.32 (0.59–4.17) | 1.32 (0.66–3.14) |
| [min–max], mg/L | [0.31–98.12] | [0.35–18.97] | [0.25–91.56] | [0.28–41.74] |
| NGAL, n | 99 | 82 | 72 | 101 |
| Median (IQR), pg/mL | 5.99 (1.98–15.31) | 5.59 (2.38–15.76) | 6.30 (1.70–17.59) | 5.48 (1.85–15.85) |
| [min–max], pg/mL | [0.46–160.79] | [0.59–325.54] | [0.49–282.04] | [0.61–160.50] |
| ACR, n | 40 | 34 | 31 | 40 |
| Median (IQR), mg/mmol | 0.8 (0.4–3.6) | 0.9 (0.6–1.8) | 0.9 (0.5–2.0) | 0.5 (0.4–1.65) |
| [min–max], mg/mmol | [0.2–37.0] | [0.2–8.5] | [0.2–7.4] | [0.3–38.8] |
Abbreviations: ACR, albumin–creatinine ratio; HDLc, high-density-lipoprotein cholesterol; HOMA-IR, homeostasis model assessment of insulin resistance; hs-CRP, high-sensitivity C-reactive protein; IL-8, interleukin 8; IQR, interquartile range; LDLc, low-density-lipoprotein cholesterol; min–max, minimum–maximum; NEFA, nonesterified fatty acid; NGAL, neutrophil gelatinase-associated lipocalin; QUICKI, Quantitative Insulin Sensitivity Check Index; SD, standard deviation; TNF-ɑ, tumor necrosis factor ɑ.