Table 2.
Metabolic, hormonal, lipids and nuclear magnetic resonance (NMR)-derived lipid particle concentrations from study visits over six months of lorcaserin or placebo treatments.
| Placebo | Lorcaserin | p | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Timing | Baseline | Month 6 | Baseline | Month 6 | |||||||||
| Glucose (mg/dL) | 92.18 | ± | 1.76 | 94.41 | ± | 2.25 | 93.28 | ± | 2.08 | 95.71 | ± | 3.02 | .75 |
| HbA1c (%) | 5.86 | ± | 0.59 | 5.82 | ± | 0.87 | 5.75 | ± | 0.71 | 5.85 | ± | 0.78 | .84 |
| C-peptide (ng/mL) | 2.65 | ± | 0.35 | 2.81 | ± | 0.46 | 2.98 | ± | 0.34 | 2.97 | ± | 0.33 | .18 |
| HOMA-IR | 3.64 | ± | 0.49 | 2.72 | ± | 0.43 | 3.91 | ± | 0.37 | 3.32 | ± | 0.56 | .22 |
| Lipoprotein Insulin Resistance Score | 55.63 | ± | 5.01 | 50.09 | ± | 5.43 | 49.28 | ± | 3.28 | 39.71 | ± | 3.59 | .05* |
| FLI | 79.95 | 5.03 | 81.62 | ± | 3.35 | 90.48 | 2.98 | 79.93 | ± | 8.66 | <.0001 | ||
| Alpha-MSH ( pmol/L) | 17.41 | ± | 2.07 | 23.65 | 3.61 | 21.91 | 1.61 | 17.95 | 4.52 | .42 | |||
| GH (ng/mL) | 0.66 | ± | 0.24 | 1.41 | ± | 0.71 | 0.81 | ± | 0.21 | 0.32 | ± | 0.11 | 1.3 |
| IGF-1 (ng/mL) | 130 | ± | 13.62 | 120 | ± | 14.81 | 137.5 | ± | 17.68 | 112.7 | ± | 16.58 | .95 |
| IGFBP3 (ng/mL) | 4.9 | ± | 0.32 | 5.31 | ± | 0.49 | 5.69 | ± | 0.56 | 5.86 | ± | 0.95 | .27 |
| Cortisol (ug/dL) | 16.27 | ± | 1.62 | 12.54 | ± | 1.98 | 16.91 | ± | 1.21 | 11.71 | ± | 1.97 | .49 |
| FGF-21 (pg/mL) | 222.47 | ± | 24.89 | 223.25 | ± | 43.59 | 268.84 | ± | 57.72 | 331.50 | ± | 77.56 | .65 |
| Leptin (pg/mL) | 33.02 | ± | 4.24 | 27.39 | ± | 4.31 | 57.2 | ± | 6.01 | 38.98 | ± | 8.56 | .05* |
| Adiponectin (pg/mL) | 14.63 | ± | 1.99 | 17.09 | ± | 2.3 | 12.67 | ± | 1.35 | 17.71 | ± | 1.91 | .9 |
| Ghrelin (pg/mL) | 513.62 | ± | 54.55 | 584.44 | ± | 28.79 | 484.97 | ± | 39.82 | 580.38 | ± | 26.01 | .84 |
| PYY (pg/mL) | 94.26 | ± | 9.23 | 83.21 | ± | 12.81 | 83.85 | ± | 5.94 | 76.86 | ± | 5.83 | 1.6 |
| GLP-1(pg/mL) | 43.90 | ± | 3.94 | 29.07 | ± | 5.42 | 40.32 | ± | 4.46 | 27.77 | ± | 3.93 | .61 |
| Oxyntomodulin (pg/mL) | 387.78 | ± | 67.94 | 161.64 | ± | 30.45 | 401.86 | ± | 57.41 | 213.67 | ± | 16.89 | .17 |
| Regular Lipids | |||||||||||||
| Total cholesterol (mg/dL) | 181.2 | ± | 7.36 | 185.8 | ± | 6.51 | 177.3 | ± | 7.12 | 174.7 | ± | 15.5 | .04* |
| Triglycerides (mg/dL) | 122.51 | ± | 8.96 | 102.4 | ± | 11.85 | 117.7 | ± | 8.85 | 96.43 | ± | 12.9 | <.001* |
| LDL cholesterol (mg/dL) | 102.7 | ± | 6.23 | 106.7 | ± | 5.81 | 106.8 | ± | 5.45 | 99.29 | ± | 12.6 | .03* |
| Non-HDL cholesterol (mg/dL) | 127.2 | ± | 6.67 | 129.6 | ± | 5.57 | 130.2 | ± | 6.51 | 118.4 | ± | 14.5 | .02* |
| HDL cholesterol (mg/dL) | 52.58 | ± | 3.37 | 53.67 | ± | 3.49 | 47.06 | ± | 2.19 | 56.29 | ± | 4.46 | .031* |
| ApoA1 (mg/dL) | 150.4 | ± | 6.11 | 150.9 | ± | 5.45 | 138.1 | ± | 4.86 | 148 | ± | 10.2 | .03* |
| ApoB (mg/dL) | 90.48 | ± | 3.81 | 86.61 | ± | 4.89 | 88.01 | ± | 5.01 | 88.29 | ± | 8.85 | .39 |
| NMR Analyis | |||||||||||||
| VLDL and Triglycerides | |||||||||||||
| Total VLDL & chylomicron particles (nmol/L) | 51.83 | ± | 4.62 | 41.33 | ± | 5.45 | 55.39 | ± | 4.57 | 42.02 | ± | 9.05 | .02* |
| Low Density Lipoproteins | |||||||||||||
| Small LDL particles (nmol/L) | 370.4 | ± | 32.5 | 465.5 | ± | 41.4 | 410.1 | ± | 25.5 | 399 | ± | 66.3 | .01* |
| oxLDL | 318.1 | ± | 21.3 | 353.7 | ± | 29 | 372.1 | ± | 28.5 | 360.4 | ± | 26.4 | .05 |
| oxLDL % change | 14.91 | ± | 2.98 | −2.47 | ± | 4.13 | .03* | ||||||
| oxLDL/LDL | 3.35 | ± | 0.23 | 3.68 | ± | 0.31 | 3.5 | ± | 0.23 | 3.9 | ± | 0.42 | .23 |
| High Density Lipoproteins | |||||||||||||
| HDL particles (µmol/L) | 29.03 | ± | 1.29 | 29.46 | ± | 1.32 | 28.51 | ± | 1.57 | 31.54 | ± | 2.43 | .03* |
| HDL cholesterol (mg/dL) | 42.01 | ± | 3.34 | 42.64 | ± | 2.31 | 42.22 | ± | 2.61 | 53.57 | ± | 5.84 | .02* |
| Large HDL particles (µmol/L) | 4.31 | ± | 0.66 | 4.39 | ± | 0.53 | 4.57 | ± | 0.46 | 6.95 | ± | 0.99 | .04* |
| HDL size (nm) | 8.97 | ± | 0.13 | 9.06 | ± | 0.12 | 9.16 | ± | 0.09 | 9.67 | ± | 0.16 | <.008* |
| Clusterin (μg/mL) | 33.12 | ± | 1.53 | 31.23 | ± | 1.72 | 33.51 | ± | 1.82 | 30.31 | ± | 1.99 | .53 |
| Clusterin %change | 0 | −8.41 | ± | 6.79 | 0 | 3.37 | ± | 13 | .77 | ||||
| oxHDL | 0.66 | ± | 0.04 | 0.6 | ± | 0.04 | 0.69 | ± | 0.03 | 0.59 | ± | 0.05 | .59 |
| oxHDL%change | 0 | −2.7 | ± | 4.31 | 0 | −1.5 | ± | 6.32 | .29 | ||||
| LIRS | 55.63 | ± | 5.01 | 50.09 | ± | 5.43 | 49.28 | ± | 3.28 | 39.71 | ± | 3.59 | .05* |
Data shown as means ± standard error (SE) of the mean from an on-treatment analysis. Patients included as long as they attended at least two visits. Hormonal measurements took place at weeks 0, 1, 2, 4, and months 3 and 6; Lipid measurements took place at weeks 0, 1, 2, 4, and months 3 and 6; oxLDL and cluserin measurement took place at Months 0, 1 and 6. The p-value is from a general linear mixed model analysis of the parameters. The variables of time, treatment and time*treatment were included in the model as fixed effects, gender, BMI, baseline values and age were included as covariates. The P-value time*treatment interaction is shown
P <0.05; HOMA-IR, homeostatic model of insulin resistance; PYY, peptide YY; GLP-1, glucagon-like peptide-1; GH, growth hormone; IGF-1, insulin-like growth factor-1; IGFBP3, Insulin-like growth factor-binding protein 3; GIP, gastric inhibitory polypeptide; FGF-21, fibroblast growth factor 21; FLI, Fatty Liver Index; VLDL, Very Low Density Lipoprotein; LDL, Low Density Lipoprotein; IDL, Intermediate Density Lipoproteins; HDL, High Density Lipoprotein; oxLDL, oxidized Low Density Lipoprotein; oxHDL, oxidized High Density Lipoprotein; LIRS, Lipoprotein Insulin Resistant Score