Table 1. Baseline characteristics.
| Characteristic | AZP-531 N = 23 |
Placebo N = 24 |
All N = 47 |
|---|---|---|---|
| Age (y) | 28.0 ± 7.7 | 25.7 ± 5.6 | 26.8 ± 6.7 |
| Median (min-max) | 26.6 (13–46) | 24.4 (19–38) | 25.5 (13–46) |
| Age group | |||
| <18 years, n | 3 | 0 | 3 |
| ≥ 18 years, n | 20 | 24 | 44 |
| Male:Female ratio, % | 65:35 | 33:67 | 49:51 |
| Deletion:non deletiona, % | 74:26 | 67:33 | 70:30 |
| IQb | 61.4 ± 12.0 | 69.8 ± 21.0 | 65.6 ± 17.3 |
| Median (min-max) | 61.0 (45–87) | 65.0 (47–127) | 62.0 (45–127) |
| Weight, kg | 87.7 ± 23.6 | 99.7 ± 26.4 | 93.8 ±25.5 |
| Median (min-max) | 87 (53–138) | 91 (65–161) | 88 (53–161) |
| BMI (kg/m2) | |||
| All patients | 35.1 ± 11.8 | 40.8 ± 11.8 | 38.0 ± 12.0 |
| Median (min-max) | 32.4 (20.6–64.6) | 38.4 (27.1–67.4) | 34.0 (20.6–67.4) |
| ≥ 18 years | 37.1 ± 11.4 | 40.8 ± 11.8 | 39.1 ± 11.6 |
| Median (min-max) | 33.7 (24.2–64.6) | 38.4 (27.1–67.4) | 34.2 (24.2–67.4) |
| WC (cm) | 106.6 ± 17.2 | 115.2 ± 18.5 | 111.0 ± 18.2 |
| Median (min-max) | 106 (80–139) | 111 (92–154) | 107 (80–154) |
| Hyperphagia severity score (/7) | 4.52 ± 0.99 | 4.46 ± 1.38 | 4.49 ± 1.20 |
| HQ total score (/55)c | 30.1 ± 9.2 | 28.5 ± 7.8 | 29.3 ± 8.5 |
| HQ 9-item score (/45) | 23.1 ± 7.7 | 21.2 ± 6.6 | 22.1 ± 7.2 |
| Current use of GH, n | 7 | 4 | 11 |
| Current use of sex hormones, n | 9 | 10 | 19 |
| Fasting glucose (mmol/L) | 5.15 ± 0.54 | 5.09 ± 0.67 | 5.12 ± 0.60 |
| Median (min-max) | 5.08 (4.3–6.3) | 4.97 (4.3–7.7) | 4.98 (4.3–7.7) |
| Fasting insulind (pmol/L) | 77.56 ± 56.18 | 83.45 ± 42.33 | 80.58 ± 49.08 |
| Median (min-max) | 56.32 (24.4–242.5) | 68.88 (38.0–181.5) | 62.42 (24.4–242.5) |
| IGT and T2D, n | 5 | 5 | 10 |
| Fasting AGe (pg/mL) | 84.81 ± 37.27 | 119.22 ± 86.96 | 102.01 ± 68.37 |
| Fasting UAGf (pg/mL) | 106.87 ± 46.42 | 158.06 ± 100.28 | 132.46 ± 81.48 |
| Fasting AG:UAG ratiod | 0.77 ± 0.24 | 0.76 ± 0.33 | 0.77 ± 0.29 |
Min-max, minimum-maximum; BMI, body mass index; HQ, hyperphagia questionnaire; GH, growth hormone; IGT, impaired glucose tolerance; IQ, intelligence quotient (specific test not performed in the context of this study, scores were collected only if available in the subjects’ medical history); T2D, Type 2 diabetes; WC, waist circumference. Data are expressed as mean ± Standard Deviation (SD) or number, unless stated otherwise.
aThe non-deletion genetic subtype includes uniparental maternal disomy and imprinting defects (when DNA methylation was used for genetic diagnosis additional testing was performed to distinguish deletion from non-deletion subtypes).
bIntelligence quotient was obtained from 14 patients in each group.
cHQ total score was obtained from 23 patients in each group.
dFasting insulin was obtained from 22 patients in the placebo group.
eAG and AG:UAG ratio were obtained from 22 patients in each group.
fUAG was obtained from 23 patients in each group.