Table 2.
Clinical End Points*
| Placebo (n = 28) | Etanercept (n = 28) | ||||
|---|---|---|---|---|---|
| End Points | Baseline | Change From Baseline |
Baseline | Change From Baseline |
P Value† |
| Inflammatory markers | |||||
| C-reactive protein, mg/L | 5.1 ± 0.7 | 0.5 ± 0.7 | 7.0 ± 0.7 | −2.4 ± 0.4 | <.001 |
| Adiponectin, µg/mL | 7.6 ± 0.7 | −0.3 ± 0.3 | 7.0 ± 0.7 | 0.8 ± 0.4 | .03 |
| Interleukin 6, ng/L | 4.5 ± 0.7 | 0.5 ± 0.5 | 5.0 ± 0.8 | −1.2 ± 0.8 | .07 |
| Fibrinogen, mg/dL‡ | 443 ± 21 | −2 ± 31 | 439 ± 20 | −68 ± 16 | .04 |
| Body composition and nutritional parameters | |||||
| BMI | 35.1 ± 0.9 | 0.0 ± 0.1 | 37.9 ± 1.1 | 0.0 ± 0.1 | .54 |
| Total fat, kg | 38.0 ± 2.1 | 0.1 ± 0.2 | 40.7 ± 2.8 | 0.0 ± 0.2 | .66 |
| Total lean mass, kg | 64.0 ± 2.5 | −0.2 ± 0.3 | 67.3 ± 2.4 | −0.1 ± 0.3 | .87 |
| VAT, cm2 | 201.9 ± 13.4 | 0.2 ± 7.0 | 213.8 ± 15.0 | 2.7 ± 5.1 | .76 |
| Total caloric intake, kcal/d | 2172 ± 163 | −142 ± 230 | 2201 ± 182 | −34 ± 157 | .73 |
| Total fat intake, g/d | 88 ± 10 | −7 ± 12 | 95 ± 9 | −1 ± 9 | .60 |
| Lipids and insulin sensitivity | |||||
| HDL-C, mg/dL | 40 ± 2 | 2 ± 1 | 39 ± 2 | −1 ± 1 | .06 |
| LDL-C, mg/dL | 117 ± 8 | −1 ± 4 | 121 ± 5 | −6 ± 4 | .55 |
| Total cholesterol, mg/dL | 190 ± 8 | 1 ± 5 | 189 ± 6 | −4 ± 4 | .54 |
| Triglycerides, mg/dL | 206 ± 36 | −5 ± 39 | 199 ± 36 | −14 ± 25 | .75 |
| FFA, mEq/L | 0.5 ± 0.0 | 0.0 ± 0.0 | 0.6 ± 0.0 | −0.1 ± 0.0 | .93 |
| SI, ×10−4 · min−1 · µIU per mL | 1.90 ± 0.36 | 0.76 ± 0.34 | 1.52 ± 0.23 | 0.33 ± 0.20 | .23 |
| Safety parameters | |||||
| WBC, ×103/µL | 6.6 ± 0.4 | −0.2 ± 0.4 | 6.5 ± 0.3 | −0.6 ± 0.3 | .35 |
| TNF-α receptors, ng/mL | |||||
| sTNFR1 | 1.33 ± 0.08 | −0.03 ± 0.06 | 1.33 ± 0.08 | 0.02 ± 0.05 | .56 |
| sTNFR2 | 2.78 ± 0.19 | −0.19 ± 0.13 | 2.99 ± 0.25 | 7.68 ± 0.42 | <.001 |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); FFA, free fatty acids; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; SI, insulin sensitivity; sTNFR1, soluble TNF-α receptor 1; sTNFR2, soluble TNF-α receptor 2; TNF-α, tumor necrosis factor α; VAT, visceral adipose tissue; WBC, white blood cell count.
SI conversion factors: To convert fibrinogen to micromoles per liter, multiply by 0.0294; to convert HDL-C, LDL-C, and total cholesterol to millimoles per liter, multiply by 0.0259.
Data are presented as mean ± SEM.
P value for comparison of treatment effect from baseline (etanercept vs placebo) for C-reactive protein, adiponectin, interleukin 6, and sTNFR2 by mixed-model analysis. P value for comparison of treatment effect from baseline (etanercept vs placebo) for all other variables by analysis of covariance. P values for comparison at baseline by t test all greater than .05.
Fibrinogen reference range is 200 to 400 mg/dL (5.9–11.8 µmol/L).