Table 1.
Participant characteristics (n= 253) at randomization and time of failure†
|
|
At randomization | At time of failure | P-value |
|---|---|---|---|
| Female (%) | 63.6% | -- | -- |
| Race-ethnicity (%) | |||
| Non-Hispanic Black | 39.5% | -- | -- |
| Hispanic | 37.2% | -- | |
| Non-Hispanic White | 16.6% | -- | |
| Other | 6.7% | -- | |
| Pubertal stage (%) | |||
| Stages 4–5 | 90.1% | 97.3% | -- |
| Stages 1–3 | 9.9% | 2.6% | |
| Diabetes duration (months) | 8.9 ± 6.4 | 29.5 ± 13.6 | P<0.0001 |
| Age (years) | 14.0 ± 2.1 | 15.6 ± 2.3 | P<0.0001 |
| HbA1c (%) | 6.4 ± 0.8 | 10.1 ± 1.9 | P<0.0001 |
| Weight (kg) | 95.9 ± 26.0 | 99.4 ± 27.0 | P<0.0001 |
| BMI (kg/m2) | 35.1 ± 7.6 | 35.4 ± 7.9 | P=0.002 |
| BMI Z-score | 2.2 ± 0.5 | 2.1 ± 0.6 | P<0.0001 |
| Total adiponectin (ng/mL) | 5478 ± 2356 | 5390 ± 3163 | P=ns |
| HMW adiponectin (ng/mL) | 2907 ± 1777 | 2834 ± 2187 | P=ns |
| 1/ fasting insulin (mL/uU) | 0.047 ± 0.037 | 0.048 ± 0.038 | P=ns |
| C-peptide index (ng/mL per mg/dL) | 0.0540 ± 0.0588 | 0.0284 ± 0.0283 | P<0.0001 |
| oDI | 0.0022 ± 0.0025 | 0.0011 ± 0.0010 | P<0.0001 |
| Hs-CRP (mg/dL) | 0.43 ± 0.96 | 0.49 ± 0.57 | P=0.004 |
| Homocysteine (μmol/L) | 6.09 ± 1.88 | 6.47 ± 1.95 | P=0.0001 |
| PAI-1 (ng/mL) | 21.8 ± 15.5 | 28.4 ± 20.9 | P<0.0001 |
| IL-6 (pg/mL) | 2.32 ± 1.89 | 2.49 ± 1.89 | P=ns |
†
HMW: high molecular weight; oDI: c-peptide based oral disposition index; hs-CRP: high sensitivity C reactive protein; PAI-1: plasminogen activator inhibitor-1; IL-6: interleukin-6; P-value from paired t-test comparing the characteristics of participants at randomization and time of failure.