Table 1.
Univariable Cox proportional hazard models predicting DPN during the study via the MNSI-exam and monofilament exam
| Abnormal MNSI-exam result | Abnormal monofilament exam result | |||||
|---|---|---|---|---|---|---|
| Characteristics (reference group or unit change) | HR | 95% CI | P value | HR | 95% CI | P value |
| Male sex (male vs. female) | 1.68 | 1.21, 2.35 | 0.002 | 2.35 | 1.16, 4.76 | 0.02 |
| Race/ethnicity (vs. non-Hispanic White) | ||||||
| Non-Hispanic Black | 1.15 | 0.70, 1.88 | 0.57 | 2.03 | 0.67, 6.16 | 0.21 |
| Hispanic | 1.30 | 0.81, 2.09 | 0.28 | 1.43 | 0.45, 4.49 | 0.54 |
| Age (per year) | 1.14 | 1.05, 1.24 | 0.002 | 1.09 | 0.91, 1.30 | 0.36 |
| Type 2 diabetes duration (per month) | 0.98 | 0.95, 1.01 | 0.15 | 0.99 | 0.93, 1.05 | 0.78 |
| Maternal diabetes (yes vs. no) | 1.17 | 0.83, 1.65 | 0.37 | 1.53 | 0.75, 3.14 | 0.24 |
| Smoking in past month (yes vs. no) | 0.99 | 0.59, 1.67 | 0.97 | 1.02 | 0.33, 3.17 | 0.97 |
| Treatment group (vs. metformin only) | ||||||
| Metformin + rosiglitazone | 0.89 | 0.60, 1.33 | 0.57 | 0.88 | 0.41, 1.90 | 0.74 |
| Metformin + intensive lifestyle | 0.82 | 0.55, 1.24 | 0.35 | 0.39 | 0.12, 1.00 | 0.05 |
| BMI (per 5 kg/m2) | 1.24 | 1.13, 1.36 | <0.0001 | 0.91 | 0.73, 1.14 | 0.42 |
| Mean HbA1c (per %)† | 1.19 | 1.10, 1.29 | <0.0001 | 1.37 | 1.15, 1.63 | 0.0004 |
| Prescribed insulin medication (yes vs. no) | 1.60 | 1.13, 2.27 | 0.008 | 5.34 | 2.03, 14.1 | 0.0007 |
| Mean SBP (per 10 mmHg)† | 1.31 | 1.10, 1.57 | 0.003 | 1.34 | 0.91, 1.95 | 0.13 |
| Mean DBP (per 10 mmHg)† | 1.25 | 0.98, 1.59 | 0.07 | 1.21 | 0.72, 2.02 | 0.47 |
| Antihypertensive medication use (yes vs. no) | 1.49 | 1.06, 2.10 | 0.02 | 2.25 | 1.11, 4.56 | 0.02 |
| Hypertension (yes vs. no) | 1.51 | 1.07, 2.14 | 0.02 | 1.16 | 0.56, 2.38 | 0.69 |
| Mean LDL cholesterol (per mg/dL)† | 1.00 | 0.99, 1.01 | 0.81 | 1.00 | 0.99, 1.02 | 0.63 |
| Mean HDL cholesterol (per mg/dL)† | 1.01 | 0.99, 1.03 | 0.35 | 0.99 | 0.96, 1.04 | 0.88 |
| Dyslipidemia (yes vs. no) | 1.08 | 0.70, 1.65 | 0.73 | 0.80 | 0.30, 2.10 | 0.65 |
| Log UACR (per SD) | 1.14 | 0.96, 1.35 | 0.14 | 1.12 | 0.79, 1.59 | 0.52 |
| Microalbuminuria (yes vs. no) | 1.38 | 0.97, 1.97 | 0.07 | 1.65 | 0.79, 3.42 | 0.18 |
| eGFR (per 10 mL/min/1.73 m2) | 1.07 | 0.99, 1.14 | 0.05 | 1.06 | 0.92, 1.22 | 0.40 |
| Hyperfiltration (yes vs. no) | 1.41 | 0.99, 1.99 | 0.05 | 1.28 | 0.63, 2.63 | 0.49 |
| Vitamin B12 level (normal [>298 pg/mL] vs. borderline low/low [≤298 pg/mL]) | 1.69 | 0.38, 7.52 | 0.49 | 0.40 | 0.04, 4.39 | 0.45 |
| Log insulin sensitivity (per SD) | 0.96 | 0.82, 1.12 | 0.61 | 0.90 | 0.65, 1.25 | 0.53 |
| Log C-peptide index (per SD) | 0.90 | 0.77, 1.05 | 0.19 | 0.63 | 0.48, 0.82 | 0.0007 |
| Log C-peptide oDI (per SD) | 0.88 | 0.76, 1.03 | 0.10 | 0.66 | 0.49, 0.88 | 0.005 |
| Log PAI-1 (per SD) | 1.26 | 1.07, 1.49 | 0.005 | 1.12 | 0.79, 1.57 | 0.53 |
| Log hs-CRP (per SD) | 1.34 | 1.12, 1.62 | 0.002 | 0.92 | 0.64, 1.34 | 0.67 |
HR, 95% CIs, and P values per reference group or unit change (as indicated) from separate univariable Cox proportional hazards model predicting the risk of abnormal MNSI-exam result or monofilament exam result during the study. Factors are entered as fixed (sex, race/ethnicity, maternal diabetes, randomized treatment group), baseline (age, diabetes duration), or as time-dependent (all other factors, assessed or measured at or at the most recent visit up to the particular time of the event or right censoring time) covariates in each of the models. DBP, diastolic blood pressure; UACR, urine albumin-to-creatinine ratio.
Time-weighted mean.