Table 1. Baseline characteristics.
For continuous variables, data are means (standard deviation) or medians (interquartile range). For categorical variables, n was used. Comparisons between INI and Placebo groups in the whole cohort and among participants with and without diagnosis of Diabetes were not statistically significant. Differences were tested by Wilcoxon rank-sum test, analysis of variance, or Fisher exact test as appropriate to determine differences at baseline between INI and placebo within each group. Intranasal Insulin (INI), African-American (AA), Body Mass Index (BMI), Basal Metabolic Rate (BMR), Fasting Plasma Glucose (FPG), Fasting Plasma Insulin (FPI).
| Demographics | All Participants | With Diabetes | Without Diabetes | |||
|---|---|---|---|---|---|---|
| INI | Placebo | INI | Placebo | INI | Placebo | |
| n=46 | n=43 | n=19 | n=19 | n=27 | n=24 | |
| Age, years | 65.5 (8.8) | 64.7 (9.6) | 63.5 (7.3) | 62.9 (9.4) | 66.9 (9.7) | 66.2 (9.8) |
| Sex, n: Male, Female | 21, 25 | 26, 17 | 8, 11 | 13, 6 | 13, 14 | 13, 11 |
| Race, n: White, AA, other | 38, 7, 1 | 29, 10, 4 | 15, 4, 0 | 8, 8, 3 | 23, 3, 1 | 21, 2, 1 |
| Ethnicity, n: Hispanic, Not Hispanic | 2, 44 | 5, 38 | 1, 18 | 3, 16 | 1, 26 | 22, 2 |
| Anthropometric measurements | n=46 | n=43 | n=19 | n=19 | n=27 | n=24 |
| Weight, kg | 79.1 (13.4) | 83.9 (19.5) | 84.9 (13.6) | 92.2 (18.8) | 74.9 (11.8) | 77.2 (17.6) |
| BMI, kg/m2 | 28.5 (5.0) | 29.9 (6.6) | 31.2 (5.0) | 32.7 (7.5) | 26.5 (4.1) | 27.5 (4.6) |
| Waist circumference, cm | 101.1 (12.5) | 103.6 (18.1) | 109.7 (9.6) | 109.7 (17.0) | 95.1 (10.8) | 98.7 (17.8) |
| Hips circumference, cm | 105.8 (11.1) | 107.7 (11.9) | 114.5 (12.5) | 110.3 (13.3) | 102.5 (8.8) | 105.7 (10.5) |
| Body composition | n=29 | n=31 | n=15 | n=16 | n=14 | n=15 |
| Fat mass, kg | 25.5 (9.3) | 27.2 (12.3) | 27.3 (9.2) | 31.9 (12.8) | 23.7 (9.5) | 22.2 (9.8) |
| Lean mass, kg | 53.9 (12.1) | 58.7 (12.1) | 56.9 (13.9) | 62.2 (10.0) | 50.6 (9.3) | 54.9 (13.3) |
| Body water, % | 52.5 (45.0–56.4) | 54.1 (45.9–56.7) | 53.1 (14.9) | 53.2 (11.9) | 49.9 (11.1) | 54.9 (9.9) |
| BMR, kcal | 1494.5 (249.8) | 1589.3 (289.6) | 1572 (273.8) | 1703.6 (224.0) | 1410.7 (197.5) | 1467.3 (308.3) |
| Food intake | n=41 | n=35 | n=17 | n=14 | n=24 | n=21 |
| Energy intake, kcal | 1768.0 (1389.5–2077.0) | 1704.0 (1411.5–2074.0) | 1574 (500) | 1635.3 (478) | 1862 (671.3) | 1808.6 (701.9) |
| Calories from fat, kcal | 587.0 (489.5–823.9) | 628.0 (504.9–784.6) | 635.7 (286.9) | 653.7 (203.8) | 684.3 (222.0) | 631.7 (295.1) |
| Calories from carbohydrates, kcal | 795.9 (647.4–920.5) | 805.5 (592.3–1122.6) | 659.9 (238.8) | 807.2 (296.9) | 916.7 (384.2) | 926.7 (380.3) |
| Calories from protein, kcal | 285.5 (228.6–354.6) | 277.5 (214.7–355.7) | 299.0 (122.1) | 351.6 (140.7) | 319.0 (128.6) | 283.0 (138.9) |
| Appetite assessment | n=46 | n=42 | n=19 | n=19 | n=27 | n=23 |
| Hunger – fasting, score | 5.0 (2.6) | 4.8 (2.9) | 5.5 (2.3) | 4.9 (3.0) | 4.6 (2.8) | 4.7 (2.9) |
| Satiety – Postprandial, score | 6.7 (2.8) | 6.7 (2.8) | 6.5 (3.1) | 5.5 (3.4) | 6.8 (2.6) | 7.8 (1.5) |
| Hours of fasting | 12.8 (2.4) | 12.9 (2.5) | 12.6 (2.2) | 13 (1.9) | 13 (2.5) | 12.8 (2.9) |
| Metabolic profile | n=46 | n=43 | n=19 | n=19 | n=27 | n=24 |
| FPG, mg/dL | 101.0 (86.8–128.8) | 96.0 (89.0–110.0) | 12.2 (11) | 13.3 (16.9) | 92 (12) | 90 (12) |
| FPI, mU/L | 9.5 (6.3–16.5) | 10.0 (6.9–16.3) | 131 (73) | 117 (46) | 7.5 (4.4) | 7.7 (4.2) |