Background
Methods
Design and setting
Study participants
Treatment protocol
Data collection
Sample size calculations
Outcome measures
Growth
Body composition
Statistical analysis
Results
Participant characteristics
Growth rates
All subjects | All subjects | All subjects | DXA Controls | |||||
---|---|---|---|---|---|---|---|---|
Baseline n=34 | 6 months n=30 | 36 months n=24 | n=241 | |||||
Mean ± sd | Range | Mean ± sd | Range | Mean ± sd | Range | Mean ± sd | Range | |
Age (years) | 7.27 ± 1.30*** | 4.71-9.12 | 7.99 ± 1.21* | 5.33-9.64 | 10.49 ± 1.22*** | 7.87-12.21 | 8.54 ± 1.93 | 4.02-11.99 |
Height (cm) | 125.5 ± 9.1* | 110.3-142.2 | 128.6 ± 9.2 | 112.6-145.6 | 140.6 ± 9.0*** | 125.5-156.0 | 130.5 ± 12.7 | 94.5-161.6 |
Weight (kg) | 27.0 ± 6.1 | 19.1-42.1 | 26.8 ± 5.9 | 19.3-42.2 | 34.4 ± 8.4** | 25.0-56.0 | 29.0 ± 8.2 | 13.1-60.4 |
BMI (kg/m2) | 17.0 ± 2.3 | 13.7-23.7 | 16.1 ± 2.3 | 12.9-23.0 | 17.3 ± 3.1 | 13.9-26.5 | 16.7 ± 2.2 | 13.3-25.6 |
Height Z-score | 0.49 ± 0.99** | −1.08-3.02 | 0.22 ± 0.95 | −1.19-2.76 | −0.07 ± 0.81 | −1.18-1.67 | −0.06 ± 0.97 | −2.24-2.07 |
Weight Z-score | 0.62 ± 0.97*** | −1.60-2.95 | 0.04 ± 1.04 | −1.86-2.63 | −0.12 ± 0.87 | −1.48-1.58 | −0.05 ± 0.92 | −2.25-2.23 |
BMI Z-score | 0.52 ± 1.02** | −1.88-2.31 | −0.17 ± 1.21 | −2.92-2.04 | −0.16 ± 1.11 | −2.45-1.97 | 0.03 ± 0.88 | −2.11-2.09 |
Time period (months: mean ± SD) | Pre-treatment | 0-6 months | 6-12 months | 12-24 months | 24-36 months |
---|---|---|---|---|---|
(16.6 ± 9.4) | (6.3 ± 1.5) | (7.3 ± 2.0) | (11.4 ± 2.1) | (10.9 ± 2.5) | |
n=11 | n=30 | n=30 | n=28 | n=24 | |
Height velocity (cm/year) | 6.5 ± 1.1 | 4.3 ± 1.9 | 4.5 ± 1.3 | 4.7 ± 1.2 | 5.3 ± 1.2 |
Weight velocity (kg/year) | 2.7 ± 1.8 | −1.5 ± 2.8 | 3.2 ± 3.1 | 2.9 ± 2.3 | 4.1 ± 2.3 |
Change in BMI/year | 0.08 ± 0.86 | −2.09 ± 1.89 | 0.81 ± 1.74 | 0.45 ± 1.05 | 0.83 ± 0.95 |
Δ Height Z-score/year | −0.04 ± 0.17 | −0.32 ± 0.38*** | −0.22 ± 0.21*** | −0.11 ± 0.19** | −0.02 ± 0.17 |
Δ Weight Z-score/year | −0.09 ± 0.36 | −1.04 ± 0.74*** | 0.03 ± 0.63 | −0.13 ± 0.27* | 0.06 ± 0.29 |
Δ BMI Z-score/year | −0.08 ± 0.44 | −1.29 ± 0.94*** | 0.26 ± 0.96 | −0.10 ± 0.39 | 0.12 ± 0.43 |
Body composition
Longitudinal changes in tissue mass
Cross sectional comparison with DXA control data controlling for age, sex and height using general linear modeling
Subjects | DXA Controls | ||||
---|---|---|---|---|---|
Baseline: n=29 (24 boys) | n=241 (105 boys) | ||||
6 months: n=23 (19 boys) | |||||
36 months n=14 (12 boys) | |||||
LS mean | Compared to DXA controls | LS mean | Comparator | ||
Lean tissue (kg) | Baseline | 20.82 | p=0.22 | 21.36 | |
6 months | 20.79 | p=0.14 | 21.51 | ||
36 months | 20.00 |
p=0.007
| 21.72 | ||
BMC (kg) | Baseline | 1.053 |
p=0.04
| 1.001 | |
6 months | 1.052 | p=0.13 | 1.011 | ||
36 months | 1.050 | p=0.46 | 1.024 | ||
BMD (kg/m2) | Baseline | 0.891 |
p<0.0001
| 0.849 | |
6 months | 0.889 |
p=0.0002
| 0.851 | ||
36 months | 0.889 |
p=0.006
| 0.854 | ||
Total fat (kg) | Baseline | 6.28 | p=0.24 | 5.55 | |
6 months | 4.84 | p=0.25 | 5.62 | ||
36 months | 5.35 | p=0.69 | 5.71 | ||
Central/total fat | Baseline | 0.421 |
p<0.0001
| 0.349 | |
6 months | 0.390 |
p=0.0009
| 0.350 | ||
36 months | 0.383 |
p=0.047
| 0.352 |
Longitudinal changes in sex and height corrected Z-scores
Blood tests
Baseline | 3 months | 3 years | |
---|---|---|---|
(n=25-31) | (n=17-25) | (n=9-15) | |
Albumin (g/L) | 45.1 ± 3.7 |
46.5 ± 3.2*
| 46.1 ± 4.1 |
Prealbumin (g/L) | 0.19 ± 0.04 | 0.19 ± 0.04 | 0.20 ± 0.04 |
Ferritin (ug/L) | 28.0 ± 12.6 | 33.0 ± 13.5 | 31.4 ± 9.4 |
Transferrin (g/L) | 2.61± 0.30 | 2.59 ± 0.39 | 2.63 ± 0.37 |
Glucose (mmol/L) | 4.55 ± 0.35 | 4.52 ± 0.39 | 4.57 ± 0.63 |
Insulin (uU/mL) | 4.23 ± 2.92 | 3.72 ± 2.37 | 3.07 ± 3.22 |
Leptin (ng/mL) | 4.45 ± 4.03 |
2.73 ± 2.03*
| 3.13 ± 1.77 |
Ghrelin (pmol/L) | 385 ± 143 | 461 ± 135 | 378 ± 204 |
IGF-1 (nmol/L) | 19.7 ± 7.3 | 18.0 ± 7.3 |
31.1 ± 18.0*
|
IGFBP-3 (ug/mL) | 4.07 ± 1.08 | 4.02 ± 0.87 |
5.82 ± 2.75*
|
P1NP (ng/mL) | 554 ± 176 |
458 ± 93*
| 620 ± 264 |
C telopeptides (pg/mL) | 0.545 ± 0.205 | 0.504 ± 0.169 |
0.886 ± 0.518*
|
Osteocalcin (ng/mL) | 50.9 ± 21.9 | 54.4 ± 13.7 |
80.9 ± 22.2**
|
Parathyroid hormone (pmol/L) | 1.40 ± 0.96 | 1.22 ± 0.62 | 1.99 ± 1.22 |
Vitamin D (nmol/L) | 67.6 ± 23.0 | 71.6 ± 21.4 | 69.1 ± 15.8 |