TABLE 1.
Keto-Med randomized trial participants’ baseline sociodemographic, anthropometric, and metabolic characteristics1
| Characteristics | WFKD → Med-Plus | Med-Plus → WFKD | Total | ASD |
|---|---|---|---|---|
| (n = 16) | (n = 17) | (n = 33) | ||
| Gender, n (%) | — | — | — | 0.17 |
| Male | 9 (56.2) | 11 (64.7) | 20 (60.6) | — |
| Female | 7 (43.8) | 6 (35.3) | 13 (39.4) | — |
| Diagnosis, n (%) | — | — | — | 0.17 |
| Prediabetes | 9 (56.2) | 11 (64.7) | 20 (60.6) | — |
| T2DM | 7 (43.8) | 6 (35.3) | 13 (39.4) | — |
| Age, years | 55.7 [52.6–67.4] | 61.0 [55.1–67.3] | 60.5 [52.7–67.3] | 0.09 |
| Highest level of education achieved, n (%) | — | — | — | 0.61 |
| High school graduate | 0 (0.0) | 2 (11.8) | 2 (6.1) | — |
| Some college | 2 (12.5) | 1 (5.9) | 3 (9.1) | — |
| College degree | 6 (37.5) | 6 (35.3) | 12 (36.4) | — |
| Some postgraduate school | 1 (6.2) | 2 (11.8) | 3 (9.1) | — |
| Postgraduate degree | 7 (43.8) | 6 (35.3) | 13 (39.4) | — |
| Race or ethnicity, n (%) | — | — | — | 0.62 |
| Non-Hispanic white | 9 (56.2) | 6 (35.3) | 15 (45.5) | — |
| Hispanic or Latinx | 2 (12.5) | 5 (29.4) | 7 (21.2) | — |
| Asian | 4 (25.0) | 4 (23.5) | 8 (24.2) | — |
| Black or African American | 0 (0.0) | 1 (5.9) | 1 (3.0) | — |
| Native Hawaiian or Pacific Islander | 1 (6.2) | 1 (5.9) | 2 (6.1) | — |
| Weight, kg | ||||
| Both sexes | 90.0 [79.8–101.3] | 84.6 [75.9–93.5] | 87.5 [75.9–95.8] | 0.29 |
| Male | 95.0 [ 81.0–104.0] | 81.3 [ 76.0–93.5] | 86.2 [74.3–95.8] | — |
| Female | 85.3 [ 77.4–93.5] | 90.2 [ 75.5–93.5] | 89.1 [76.5–97.3] | — |
| BMI, kg/m2 | ||||
| Both sexes | 30.4 [27.6–35.6] | 31.0 [27.1–35.2] | 30.6 [27.1–34.6] | 0.11 |
| Male | 35.5 [30.2–36.0] | 31.3 [28.4–37.2] | 28.1 [24.9–30.6] | — |
| Female | 27.4 [24.5–29.4] | 29.5 [ 26.4–33.3] | 32.7 [29.6–36.2] | — |
| Blood pressure, mmHg | ||||
| Systolic | 126.5 [113.5–132.0] | 123.5 [113.5–129.8] | 122.0 [113.5–128.5] | 0.27 |
| Diastolic | 75.0 [68.3–80.5] | 72.8 [68.1–77.9] | 74.5 [69.0–79.5] | 0.09 |
| HbA1c levels, % | ||||
| All participants | 6.1 [5.9–6.8] | 6.0 [5.6–6.6] | 6.0 [5.7–6.9] | 0.23 |
| Prediabetes | 6.0 [5.7–6.0] | 5.70 [5.5–6.0] | 5.8 [5.7–6.0] | — |
| T2DM | 6.9 [6.5–7.2] | 6.85 [6.7–7.0] | 7.0 [6.0–7.5] | — |
| Fasting glucose, mg/dL | ||||
| All participants | 120.0 [111.8–134.3] | 118.0 [106.0–134.0] | 115 [105–133] | 0.01 |
| Prediabetes | 114.0 [108.0–117.0] | 106.0 [101.0–117.5] | 110 [100.5–115.3] | — |
| T2DM | 138.0 [123.5–142.0] | 147.0 [137.0–161.5] | 137 [122–149] | — |
| Fasting insulin, µIU/mL | ||||
| All participants | 14.7 [12.5–22.1] | 16.5 [11.5–19.2] | 15.4 [12.1–24.3] | 0.06 |
| Prediabetes | 14.4 [12.0–22.1] | 18.0 [13.3–19.4] | 16.2 [12.0–23.9] | — |
| T2DM | 14.7 [13.7–19.6] | 12.4 [7.8–17.9] | 14.9 [12.4–25.3] | — |
| Blood lipids, mg/dL | ||||
| LDL cholesterol | 101.0 [78.0–115.3] | 116.0 [93.0–129.0] | 107 [75–132] | 0.49 |
| HDL cholesterol | 47.0 [41.0–56.0] | 46.0 [42.0–56.0] | 48 [41–54] | 0.09 |
| Triglycerides | 99.5 [88.8–131.0] | 108.0 [82.0–163.0] | 105 [88–157] | 0.19 |
| Alanine aminotransferase, IU/L | 26.5 [20.8–36.5] | 25.0 [20.0–34.0] | 24 [17–40] | 0.06 |
| Medication, n | ||||
| Metformin only | 4 | 6 | 10 | — |
| Metformin + sulfonylurea | 5 | 3 | 8 | — |
| Other | 1 | 0 | 1 | — |
1
Values are n (%) and median [IQR]. Abbreviations: ASD, absolute standardized difference; HbA1c, glycated hemoglobin; Med-Plus, Mediterranean-plus diet; T2DM, type 2 diabetes mellitus; WFKD, well-formulated ketogenic diet.