TABLE 3.
Insulin Sensitizer Effect on Atherothrombotic and Inflammatory Profiles After 3 Months of Treatment With Insulin Sensitizer or Placeboa
| Variableb,c | Insulin sensitizer (n=12) |
Placebo (n=13) |
Between groups |
|||||
|---|---|---|---|---|---|---|---|---|
| Baseline | 3 mo | Change | Baseline | 3 mo | Change | Unadjusted P value | Adjusted P value | |
| Demographic characteristics | ||||||||
| Age (y) | 52.5 (15.6) | 52.2 (18.2) | >.99 | – | ||||
| Female, No. (%) | 7 (58) | 8 (62) | .87 | – | ||||
| BMI | 32.43 (5.53) | 32.89 (5.49) | 0.49 (0.61) | 29.60 (3.23) | 29.42 (3.11) | −0.18 (0.46) | <.001 | – |
| FFM (kg) | 48.81 (14.98) | 47.68 (12.91) | −1.13 (2.75) | 46.67 (13.27) | 46.33 (13.52) | −0.34 (1.26) | .65 | – |
| Body fat (%) | 46.49 (5.79) | 48.22 (4.73) | 1.73 (3.01) | 43.26 (8.99) | 43.25 (8.68) | −0.01 (1.41) | .06 | – |
| Glycemic control | ||||||||
| Glucose (mg/dL) | 126.25 (21.39) | 106.29 (12.98) | −19.96 (13.71) | 129.00 (25.79) | 137.39 (43.96) | 8.39 (22.06) | <.001 | – |
| HbA1c (%) | 5.97 (0.69) | 5.62 (0.59) | −0.35 (0.39) | 6.25 (0.64) | 6.43 (1.12) | 0.19 (0.56) | .001 | – |
| Insulin sensitivity | ||||||||
| GIR (μm/kg of FFM/min) | 22.28 (14.35) | 40.23 (13.07) | 17.95 (8.41) | 23.40 (14.96) | 25.08 (17.81) | 1.68 (7.41) | <.001 | – |
| Insulin (μU/mL) | 15.68 (9.54) | 8.26 (3.87) | −8.13 (7.29) | 10.18 (5.58) | 11.55 (6.96) | 1.38 (3.22) | <.001 | – |
| Lipid profile | ||||||||
| Triglycerides (mg/dL) | 131.42 (53.55) | 115.83 (54.10) | −15.58 (31.95) | 135.00 (50.33) | 152.77 (62.95) | 17.77 (28.29) | .003 | .02 |
| HDL-C (mg/dL) | 43.33 (12.50) | 47.67 (14.13) | 4.33 (6.60) | 39.23 (8.53) | 38.92 (9.84) | −0.31 (3.82) | .01 | .03 |
| Non–HDL-C (mg/dL) | 135.58 (25.59) | 128.08 (32.73) | −7.50 (14.95) | 132.46 (21.21) | 137.08 (27.41) | 4.62 (17.40) | .01 | .03 |
| Thrombotic markers | ||||||||
| Fibrinogen (mg/dL) | 393.67 (76.90) | 407.67 (103.83) | 14.00 (69.67) | 418.92 (98.20) | 400.31 (62.19) | −18.62 (61.64) | .09 | .09 |
| PAI-1 (ng/dL) | 8.18 (2.15) | 4.77 (2.53) | −3.42 (2.48) | 5.59 (3.30) | 6.40 (2.69) | 0.82 (3.01) | <.001 | .001 |
| Inflammatory markers | ||||||||
| CRP (mg/dL) | 0.42 (0.42) | 0.23 (0.23) | −0.19 (0.22) | 0.43 (0.48) | 0.28 (0.23) | −0.15 (0.52) | .006 | .03 |
| IL-6 (pg/mL) | 2.46 (1.64) | 1.47 (0.57) | −0.99 (1.41) | 3.28 (4.69) | 1.85 (0.72) | −1.42 (4.74) | .04 | .07 |
| TNF-α (pg/mL) | 1.40 (0.55) | 1.26 (0.51) | −0.13 (0.20) | 2.98 (5.23) | 3.15 (5.22) | 0.18 (0.36) | .001 | .008 |
| Adiponectin (mg/mL) | 6.08 (2.13) | 15.24 (6.63) | 9.1 (5.10) | 5.22 (2.09) | 5.68 (2.80) | 4.61 (0.91) | <.001 | .001 |
BMI = body mass index; CRP = C-reactive protein; FFM = fat-free mass; GIR = glucose infusion rate; HbA1c = glycosylated hemoglobin; HDL-C = high-density lipoprotein cholesterol; IL-6 = interleukin 6; NEA = Northern European Americans without diabetes; PAI-1 = plasminogen activator inhibitor 1; TNF-α = tumor necrosis factor α.
SI conversion factors: To convert glucose levels to mmol/L, multiply by 0.0555; to convert insulin levels to pmol/L, multiply by 6.945; to convert triglyceride levels to mmol/L, multiply by 0.0113; to convert HDL-C levels to mmol/L, multiply by 0.0259; to convert non–HDL-C levels to mmol/L, multiply by 0.0259; to convert fibrinogen levels to μmol/L, multiply by 0.0294; and to convert CRP levels to mg/L, multiply by 10.
The GIR was calculated as mean rate of glucose infusion maintaining euglycemia during hours 4 through 8 of an 8-hour insulin and essential amino acid infusion. Data are mean ± SD. P values are from Wilcoxon rank sum comparisons of the change scores between groups. Both unadjusted and adjusted (Hochberg) P values are reported.