Table 1.
Cohort Details and Blood Parameters of IN Insulin- and Placebo-Treated Subjects at Baseline and After 4 Weeks of Treatment
| Characteristic | Baseline | Week 4 | ||||
|---|---|---|---|---|---|---|
| Placebo | Insulin | P Value (vs Placebo) | Placebo | Insulin | P Value (vs Placebo) | |
| Cohort details | ||||||
| Age, y | 29 ± 3 | 36 ± 4 | 0.20 | |||
| Weight, kg | 83.4 ± 2 | 84.0 ± 3 | 0.87 | 83.2 ± 2 | 84.9 ± 3 | 0.65 |
| Waist circumference, cm | 87 ± 3 | 89 ± 2 | 0.70 | 90 ± 2 | 89 ± 3 | 0.94 |
| Waist to hip ratio | 0.84 ± 0.03 | 0.86 ± 0.03 | 0.73 | 0.88 ± 0.02 | 0.86 ± 0.03 | 0.67 |
| BMI, kg/m2 | 25.4 ± 0.5 | 24.6 ± 0.7 | 0.34 | 25.3 ± 0.5 | 24.8 ± 0.7 | 0.54 |
| Glucose metabolism | ||||||
| HOMA | 2 ± 0.3 | 1.5 ± 0.2 | 0.20 | 1.7 ± 0.3 | 1.2 ± 0.1 | 0.14 |
| Matsuda index | 6.6 ± 1.3 | 8.2 ± 1.4 | 0.40 | 7.1 ± 0.6 | 8.5 ± 1.3 | 0.38 |
| HbA1c, % | 4.9 ± 0.1 | 4.9 ± 0.1 | 0.86 | 4.9 ± 0.1 | 4.9 ± 0.1 | 0.87 |
| Insulin, µU/mL | 9 ± 1.2 | 7.6 ± 1.1 | 0.36 | 7.9 ± 0.9 | 5.9 ± 0.5 | 0.08 |
| C-peptide, ng/mL | 2.0 ± 0.2 | 2.1 ± 0.2 | 0.90 | 2.0 ± 0.2 | 1.8 ± 0.2 | 0.65 |
| Glucose, mg/dL | 85 ± 5 | 80 ± 5 | 0.51 | 85 ± 5 | 83 ± 2 | 0.66 |
| Lipid parameters | ||||||
| Triglycerides, mg/dL | 91 ± 16 | 108 ± 21 | 0.52 | 85 ± 8 | 117 ± 26 | 0.25 |
| Free fatty acids, µmol/L | 321 ± 70 | 318 ± 80 | 0.98 | 419 ± 78 | 301 ± 42 | 0.18 |
| Cholesterol, mg/dL | 159 ± 7 | 192 ± 14 | 0.05 | 161 ± 7 | 196 ± 13 | 0.03 |
| HDL, mg/dL | 46 ± 3 | 54 ± 5 | 0.19 | 49 ± 3 | 54 ± 4 | 0.35 |
| LDL, mg/dL | 95 ± 7 | 116 ± 13 | 0.17 | 95 ± 5 | 118 ± 12 | 0.08 |
| Non-HDL, mg/dL | 113 ± 7 | 138 ± 16 | 0.18 | 106 ± 8 | 142 ± 16 | 0.07 |
| Protein metabolism | ||||||
| Creatinine, mg/dL | 0.90 ± 0.03 | 0.97 ± 0.04 | 0.15 | 0.89 ± 0.04 | 0.97 ± 0.04 | 0.23 |
| Total protein, g/L | 69 ± 1 | 70 ± 1 | 0.65 | 70 ± 1 | 69 ± 1 | 0.71 |
| Albumin, g/L | 47 ± 0.6 | 46 ± 1.2 | 0.80 | 46 ± 0.7 | 47 ± 0.8 | 0.41 |
| Endocrine parameters | ||||||
| Thyrotropin, µU/mL | 2.4 ± 0.3 | 2.5 ± 0.3 | 0.81 | 2.5 ± 0.3 | 2.4 ± 0.3 | 0.86 |
| Free thyroxine, ng/dL | 1.22 ± 0.22 | 1.33 ± 0.06 | 0.13 | 1.25 ± 0.05 | 1.22 ± 0.05 | 0.68 |
| Luteinizing hormone, mU/mL | 4.0 ± 0.4 | 4.9 ± 0.6 | 0.23 | 4.4 ± 0.5 | 4.8 ± 0.5 | 0.50 |
| Follicle-stimulating hormone, mU/mL | 3.5 ± 0.7 | 4.7 ± 0.7 | 0.21 | 3.7 ± 0.6 | 4.4 ± 0.5 | 0.37 |
| Free testosterone, ng/mL | 2.5 ± 0.2 | 3.4 ± 0.8 | 0.29 | 2.7 ± 0.3 | 2.6 ± 0.3 | 0.79 |
| Prolactin, ng/mL | 11 ± 1 | 11 ± 2 | 0.70 | 12 ± 1 | 9 ± 1 | 0.16 |
| Somatotropin, ng/mL | 1 ± 0.7 | 0.8 ± 0.3 | 0.79 | 0.3 ± 0.1 | 0.8 ± 0.4 | 0.20 |
| IGF-1, ng/mL | 269 ± 25 | 234 ± 20 | 0.29 | 253 ± 16 | 244 ± 21 | 0.73 |
| Cortisol, µg/dL | 22.1 ± 2.1 | 18.0 ± 0.8 | 0.10 | 17.9 ± 2.1 | 12.2 ± 0.9a | 0.02 |
All values are mean ± SEM; n = 10 per group.
Abbreviations: BMI, body mass index; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; HOMA, homeostatic model assessment; IGF-1, insulin-like growth factor 1.
a
Paired t test (baseline vs week 4), P < 0.01.