Table 3. Change in Metabolic Risk Factors From Baseline, Within and Between Groups.
| Variable | Change from baseline (95% CI) | Difference in change from baseline, intervention vs control group (95% CI) | P value | |
|---|---|---|---|---|
| Low-carbohydrate diet (n = 75) | Usual diet (n = 75) | |||
| Primary and secondary outcomes | ||||
| Hemoglobin A1c, % | ||||
| 3 mo | –0.23 (–0.31 to –0.15) | –0.07 (–0.11 to –0.02) | –0.16 (–0.25 to –0.07) | <.001 |
| 6 moa | –0.26 (–0.33 to –0.19) | –0.04 (–0.10 to 0.02) | –0.23 (–0.32 to –0.14) | <.001 |
| Fasting plasma glucose, mg/dL | ||||
| 3 mo | –2.4 (–6.3 to 1.5) | 5.6 (1.3 to 9.8) | –8.0 (–13.7 to –2.2) | .007 |
| 6 mo | –8.4 (–12.3 to –4.5) | 1.9 (–1.8 to 5.5) | –10.3 (–15.6 to –4.9) | .001 |
| Systolic blood pressure, mm Hg | ||||
| 3 mo | –4.2 (–6.7 to –1.7) | –0.2 (–2.6 to 2.2) | –4.0 (–7.5 to –0.5) | .03 |
| 6 mo | –4.9 (–7.9 to –1.8) | –1.6 (–4.4 to 1.2) | –3.2 (–7.3 to 0.9) | .12 |
| Total-to-HDL cholesterol, mg/dL | ||||
| 3 mo | –0.46 (–0.59 to –0.33) | –0.41 (–0.52 to –0.30) | –0.05 (–0.22 to 0.12) | .57 |
| 6 mo | –0.54 (–0.67 to –0.40) | –0.41 (–0.52 to –0.29) | –0.13 (–0.31 to 0.05) | .15 |
| Body weight, kg | ||||
| 3 mo | –4.6 (–5.5 to –3.6) | –0.4 (–0.9 to 0.1) | –4.1 (–5.2 to –3.1) | <.001 |
| 6 mo | –6.4 (–7.8 to –5.1) | –0.5 (–1.2 to 0.2) | –5.9 (–7.4 to –4.4) | <.001 |
| Exploratory outcomes | ||||
| Fasting insulin, μIU/L | ||||
| 3 mo | –4.1 (–6.9 to –1.3) | 1.5 (–1.0 to 4.0) | –5.6 (–9.4 to –1.8) | .004 |
| 6 mo | –4.0 (–7.2 to –0.8) | 2.3 (–0.5 to 5.0) | –6.2 (–10.5 to –2.0) | .004 |
| Homeostasis model assessment of insulin resistance | ||||
| 3 mo | –1.2 (–2.1 to –0.2) | 0.9 (0 to 1.8) | –2.0 (–3.3 to –0.7) | .002 |
| 6 mo | –1.6 (–2.6 to –0.7) | 0.8 (–0.2 to 1.7) | –2.4 (–3.7 to –1.1) | <.001 |
| Diastolic blood pressure, mm Hg | ||||
| 3 mo | –3.2 (–4.8 to –1.7) | –0.1 (–1.9 to 1.8) | –3.2 (–5.6 to –0.8) | .01 |
| 6 mo | –3.2 (–5.2 to –1.2) | –0.6 (–2.3 to 1.1) | –2.6 (–5.2 to 0) | .05 |
| Waist circumference, cm | ||||
| 3 mo | –3.0 (–4.3 to –1.7) | –0.5 (–1.2 to 0.3) | –2.5 (–4.0 to –1.0) | .001 |
| 6 mo | –5.2 (–6.9 to –3.5) | –0.5 (–1.6 to 0.5) | –4.7 (–6.7 to –2.6) | <.001 |
| 10-y Atherosclerotic cardiovascular disease risk, % | ||||
| 3 mo | –1.2 (–2.1 to –0.4) | –0.4 (–1.0 to 0.1) | –0.8 (–1.8 to 0.2) | .11 |
| 6 mo | –1.7 (–2.5 to –0.9) | –0.9 (–1.6 to –0.2) | –0.8 (–1.8 to 0.3) | .14 |
| HDL, mg/dLb | ||||
| 3 mo | 3.1 (1.2 to 4.9) | 3.0 (1.6 to 4.4) | 0.1 (–2.2 to 2.4) | .94 |
| 6 mo | 5.2 (3.5 to 7.0) | 3.4 (1.7 to 5.1) | 1.9 (–0.5 to 4.3) | .13 |
| Low-density lipoprotein, mg/dLb | ||||
| 3 mo | 5.8 (2.4 to 9.3) | 2.9 (–1.6 to 7.5) | 2.9 (–2.8 to 8.6) | .32 |
| 6 mo | 3.2 (–0.8 to 7.1) | 4.2 (–0.6 to 9.0) | –1.1 (–7.3 to 5.2) | .74 |
Abbreviation: HDL, high-density lipoprotein.
SI conversion factors: To convert glucose to mmol/L, multiply by 0.0555; insulin to pmol/L, multiply by 6.945; total cholesterol to mmol/L, multiply by 0.0259; HDL cholesterol to mmol/L, multiply by 0.0259; low-density lipoprotein cholesterol to mmol/L, multiply by 0.0259; triglycerides to mmol/L, multiply by 0.0113.
a
Primary outcome is 6-month change in hemoglobin A1c.
b
Refers to post hoc exploratory outcomes.