Table 2.
Effect of lifestyle intervention on primary and secondary outcomes
| HL (N = 50) | ILI (N = 50) | Difference (95% CI) | P † | |
|---|---|---|---|---|
| Primary outcome | ||||
| HbA1c (%) | ||||
| Baseline | 7.3 ± 0.2 | 7.5 ± 0.2 | ||
| Change at 6 months | −0.1 ± 0.1 | −0.7 ± 0.1‡ | ||
| Change at 1 year | 0.1 ± 0.1 | −0.8 ± 0.1‡ | 0.9 (0.5, 1.2) | <0.001 |
| HbA1c (mmol/mol) | ||||
| Baseline | 55.7 ± 1.9 | 58.2 ± 0.2 | ||
| Change at 6 months | −2.6 ± 1.8 | −9.2 ± 1.8‡ | ||
| Change at 1 year | −0.8 ± 1.9 | −12.2 ± 1.9‡ | 11.8 (5.0, 18.9) | <0.001 |
| Secondary outcomes | ||||
| Insulin sensitivity and secretion | ||||
| SIComposite | ||||
| Baseline | 2.4 ± 0.3 | 2.1 ± 0.3 | ||
| Change at 6 months | −0.0 ± 0.2 | 0.9 ± 0.2§ | ||
| Change at 1 year | −0.4 ± 0.2 | 1.2 ± 0.2‡ | 1.6 (−2.2, −0.9) | <0.001 |
| HOMA-IR | ||||
| Baseline | 11.3 ± 2.3 | 13.4 ± 2.8 | ||
| Change at 6 months | 1.9 ± 1.2 | −2.6 ± 1.2§ | ||
| Change at 1 year | 4.1 ± 1.2 | −2.5 ± 1.4§ | 6.8 (2.0, 11.7) | 0.03 |
| Static DI, Φs (109 min−1) | ||||
| Baseline | 91.7 ± 15.8 | 80.4 ± 19.8 | ||
| Change at 6 months | −6.9 ± 13.9 | 42.9 ± 13.5ǁ | ||
| Change at 1 year | −17.2 ± 14.7 | 58.2 ± 15.2§ | 76.5 (−127.8, −25.4) | 0.02 |
| Dynamic DI, Φd (109) | ||||
| Baseline | 1,595 ± 406 | 1,334 ± 347 | ||
| Change at 6 months | 286 ± 201 | 426 ± 192 | ||
| Change at 1 year | −162 ± 211 | 530 ± 215 | 757 (−1,529, 16) | 0.14 |
| Overall DI, Φo (109 min−1) | ||||
| Baseline | 55.6 ± 8.3 | 51.4 ± 10.2 | ||
| Change at 6 months | −4.9 ± 7.7 | 23.7 ± 7.9ǁ | ||
| Change at 1 year | −13.0 ± 8.4 | 26.0 ± 8.9ǁ | −39.2 (−70.2, −8.3) | 0.04 |
| Glucose tolerance variables | ||||
| Fasting glucose (mmol/L) | ||||
| Baseline | 7.1 ± 0.3 | 7.6 ± 0.3 | ||
| Change at 6 months | 0.3 ± 0.2 | −0.4 ± 0.2 | ||
| Change at 1 year | 0.8 ± 0.2ǁ | −0.6 ± 0.3§ | 1.7 (0.8, 2.6) | 0.004 |
| 2-h glucose (mmol/L) | ||||
| Baseline | 14.9 ± 0.8 | 16.4 ± 0.7 | ||
| Change at 6 months | 0.2 ± 0.4 | −1.7 ± 0.3‡ | ||
| Change at 1 year | 0.5 ± 0.4 | −1.6 ± 0.2‡ | 2.3 (1.0, 3.7) | 0.001 |
| Glucose AUC (mmol/L per 2 h) | ||||
| Baseline | 1,573 ± 65 | 1,644 ± 51 | ||
| Change at 6 months | 51 ± 43 | −102 ± 42 | ||
| Change at 1 year | 123 ± 44 | −135 ± 47ǁ | 237 (104, 421) | 0.009 |
| Insulin AUC (×103 pmol/L per 2 h) | ||||
| Baseline | 64.9 ± 9.1 | 66.2 ± 9.5 | ||
| Change at 6 months | 1.3 ± 3.2 | −12.2 ± 3.1§ | ||
| Change at 1 year | 3.8 ± 3.2 | −9.8 ± 3.5ǁ | 13.2 (1.4, 25.0) | 0.04 |
| C-peptide AUC (nmol/L per 2 h) | ||||
| Baseline | 340.9 ± 32.4 | 324.4 ± 31.8 | ||
| Change at 6 months | 9.6 ± 12.6 | −30.5 ± 12.6 | ||
| Change at 1 year | 17.2 ± 17.2 | −38.4 ± 13.9ǁ | 54.0 (8.6, 99.3) | 0.04 |
| Glucagon AUC (ng/L per 2 h) | ||||
| Baseline | 2,429 ± 178 | 2,416 ± 175 | ||
| Change at 6 months | 60 ± 76 | −225 ± 77ǁ | ||
| Change at 1 year | 141 ± 79 | −226 ± 78ǁ | 369 (82, 656) | 0.03 |
| Body weight and composition | ||||
| Weight (kg) | ||||
| Baseline | 100.5 ± 0.3 | 102.2 ± 0.2 | ||
| Change at 6 months | 0.9 ± 0.6 | −8.0 ± 0.6‡ | ||
| Change at 1 year | −0.3 ± 0.6 | −8.4 ± 0.6‡ | 8.1 (6.1, 10.2) | <0.001 |
| Fat mass (kg) | ||||
| Baseline | 41.3 ± 1.6 | 43.8 ± 1.5 | ||
| Change at 6 months | −0.3 ± 0.4 | −6.0 ± 0.4‡ | ||
| Change at 1 year | −0.4 ± 0.4 | −6.6 ± 0.5‡ | 6.2 (4.6, 7.8) | <0.001 |
| Visceral adipose tissue (cm3) | ||||
| Baseline | 1,196 ± 57 | 1,203 ± 50 | ||
| Change at 6 months | −33 ± 25 | −173 ± 26‡ | ||
| Change at 1 year | −30 ± 27 | −261 ± 29‡ | 234 (131, 337) | <0.001 |
| LBM (kg) | ||||
| Baseline | 59.3 ± 1.5 | 58.5 ± 1.6 | ||
| Change at 6 months | 0.3 ± 0.3 | −1.7 ± 0.3‡ | ||
| Change at 1 year | 0.2 ± 0.3 | −1.7 ± 0.3‡ | 1.8 (0.8, 2.9) | 0.001 |
| Physical function and quality of life | ||||
| PPT score | ||||
| Baseline | 28.1 ± 0.7 | 28.9 ± 0.6 | ||
| Change at 6 months | 0.6 ± 0.4 | 2.7 ± 0.4‡ | ||
| Change at 1 year | −0.1 ± 0.4 | 2.9 ± 0.4‡ | −2.9 (−4.3, −1.5) | <0.001 |
| VO2peak (mL/kg/min) | ||||
| Baseline | 16.5 ± 0.6 | 16.5 ± 0.4 | ||
| Change at 6 months | −0.9 ± 0.2‡ | 2.2 ± 0.2‡ | ||
| Change at 1 year | −1.2 ± 0.2‡ | 2.2 ± 0.3‡ | −3.4 (−4.4, −24) | <0.001 |
| Total 1-RM strength (kg) | ||||
| Baseline | 303 ± 15 | 304 ± 14 | ||
| Change at 6 months | 3 ± 4 | 54 ± 4‡ | ||
| Change at 1 year | −1 ± 4 | 46 ± 4‡ | −46 (−55, −39) | <0.001 |
| Gait speed (m/min) | ||||
| Baseline | 70.2 ± 2.8 | 76.2 ± 1.9 | ||
| Change at 6 months | −1.7 ± 1.2 | 4.9 ± 1.2‡ | ||
| Change at 1 year | −3.7 ± 1.2ǁ | 7.2 ± 1.3‡ | −10.1 (−14.4, −5.8) | <0.001 |
| Physical activity (MET h/day) | ||||
| Baseline | 9.3 ± 0.3 | 9.6 ± 0.3 | ||
| Change at 6 months | −0.3 ± 0.2 | 3.1 ± 0.2‡ | ||
| Change at 1 year | −0.4 ± 0.2 | 2.8 ± 0.2‡ | −3.1 (−3.9, −2.4) | <0.001 |
| FSQ score | ||||
| Baseline | 28.4 ± 0.7 | 29.7 ± 0.5 | ||
| Change at 6 months | −0.9 ± 0.3 | 1.4 ± 0.3‡ | ||
| Change at 1 year | −1.0 ± 0.3 | 1.9 ± 0.3‡ | −2.9 (−4.1, −1.7) | <0.001 |
| SF-36 PCS score | ||||
| Baseline | 43.1 ± 1.4 | 44.1 ± 1.3 | ||
| Change at 6 months | −2.0 ± 0.9 | 4.0 ± 0.9‡ | ||
| Change at 1 year | −4.9 ± 0.9‡ | 4.9 ± 1.0‡ | −9.6 (−12.9, −6.2) | <0.001 |
Baseline values are observed means ± SE, and change score values are least squares–adjusted means ± SE from repeated-measures ANCOVAs.
P values for comparison between the groups of changes from baseline to 1 year were calculated with use of mixed-model repeated-measures ANCOVA (with baseline values and sex as covariates) and are reported where the overall P value was <0.05 for the interaction among the groups over time. Benjamini-Hochberg correction for multiple comparisons was used to adjust the P values in the secondary outcomes.
P < 0.001 for comparison of the value at the follow-up time with the baseline value within the group, as calculated with use of mixed-model repeated-measures ANOVA.
P < 0.01 for comparison of the value at the follow-up time with the baseline value within the group, as calculated with use of mixed-model repeated-measures ANOVA.
P < 0.05 for comparison of the value at follow-up time with the baseline value within the group, as calculated with use of mixed-model repeated-measures ANOVA.