Table 2.

Adjusted Means for Each Outcome Measure at Baseline, at 12 Months of Growth Hormone Treatment and at 24 Months When Off Treatment for 12 months for Individuals with Prader-Willi Syndrome

	Total
	Baseline		12 months		24 months
Variables	M	SE	M	SE	M	SE
Weight (kg)	84.6	4.9	85.2	5.0	88.0	5.2
Height (cm)	149.1	1.3	149.6	1.4	149.5	1.4
Body mass index (BMI)	37.7	2.0	37.6	2.0	38.8	2.1
Abdomen circumference (cm)	112.4	5.3	114.8	5.8	112.6	6.2
Hip circumference (cm)	114.8	4.1	109.8	4.7	112.8	5.1
Body composition
Total bone mineral density (BMD)	1.14	0.05	1.12	0.05	1.15	0.05
Total lean (g)	39 955**	2 727	42 301	2 749	40 386*	2 785
Total tissue fat (g)	81 941	4 830	82 644	4 959	85 157	5 170
Total regional fat (g)	41 987	3 118	40 561	3 259	44 959	3 489
Percent body fat	51.2*	2.1	48.5	2.2	52.1**	2.3
Whole-room chamber
Energy intake (%)
Fat	50.0	4.1	53.6	4.6	58.0	5.1
Carbohydrate	46.3	4.0	43.4	4.5	39.3	4.9
Protein	3.7	0.4	3.0	0.5	2.8	0.6
Energy expenditure (kcal)
8 hr	738	49	752	53	806	58
24 hr (extrapolated)	2 215	146	2 257	160	2 417	174
Metabolic rate (kcal/min)	1.54	0.10	1.57	0.11	1.68	0.12
Respiratory quotient (RQ)	0.85	0.01	0.83	0.01	0.82	0.01
Resting metabolic rate (RMR) (kcal)	1 845	161	1 919	203	1 914	278
RMR RQ (during first hour)	0.82	0.02	0.80	0.03	0.82	0.04
Physical activity
Physical activity/Average counts/min	177	27	256	33	215	49
Activity min/day
Sedentary	612	20	547	24	581	37
Light	214	12	218	14	225	21
Moderate	10.7	4.0	22.8	4.8	15.7	7.3
Vigorous	0.07	0.52	1.06	0.62	0.18	0.93
Bouts/day
Moderate/Vigorous	0.18**	0.12	0.73	0.13	0.26	0.19
Vigorous	0.00	0.02	0.04	0.02	0.00	0.04
Bout lengths/day (min)
Moderate/Vigorous	4.6*	2.4	12.5	2.8	6.1	4.0
Vigorous	0.00	0.44	0.90	0.53	0.00	0.80
Strength index	93	11	104	12	106	15
Laboratory
Insulin-like growth factor I (IGF-I) (ng/ml) (reference range 98–553)	93**	37.6	385	48.6	140**	53.1
Glucose (mg/dl) (range 65–110)	101	12	116	13	98	14
Insulin (mcU/ml) (range 2–18)	22.3	4.0	26.3	5.3	15.9	5.8
HOMA† (insulin resistance): glucose (mg/dl) × insulin (mcU/ml) /405	5.7	1.5	1.0	1.9	7.2	1.9
Free T4 (ng/dl) (range 0.8–1.9)	2.7	0.8	2.2	1.5	2.1	1.5
Thyroid stimulating hormone (TSH) (mcU/ml) (range 0.35–5.50)	1.3	0.2	3.1	0.7	0.7	0.7
Cholesterol (mg/dl) (range 140–200)	180	10.3	176	11.6	164	13.0
Triglyceride (mg/dl) (range 30–200)	123	10.0	116	11.8	113	12.9
High density lipoprotein (HDL) (mg/dl)	51	3.5	55	3.8	46*	4.1
Low density lipoprotein (LDL) (mg/dl)	108	8.1	95	9.0	93	10.3
Very low density lipoprotein (VLDL) (mg/dl)	24.2	2.0	23.1	2.3	22.6	2.6
Dietary
Daily total energy intake (kcal)	1 419	235	1 442	244	1 291	267
Daily fat kcal (%)	29.2	2.0	30.6	2.4	35.1	3.2
Daily carbohydrate kcal (%)	52.9	3.0	54.8	3.5	48.2	4.9
Daily protein kcal (%)	20.0	1.3	17.7	1.6	19.6	2.5
Quality of life	9.4	1.9	8.7	2.0	10.5	2.2
SF-36
Dimension 1 Physical functioning	72	6	80	7	70	9
Dimension 2 Role limitations/physical health	74	11	69	12	75	17
Dimension 3 Role limitations/emotional health	82	12	66	13	97	16
Dimension 4 Energy/fatigue	53	7	67	8	52	11
Dimension 5 Emotional well being	81	5	84	5	88	6
Dimension 6 Social functioning	81	5	85	5	92	6
Dimension 7 Pain	72	8	82	9	60	10*
Dimension 8 General health	73	6	67	6	75	8

^*p < 0.05;

^**p < 0.01 for fixed effect within-subject (time) comparison using 12 months as a reference point M = mean; SE = standard error

^†Homeostasis model assessment (HOMA), an indicator of insulin resistance is represented by the following equation: glucose (mg/dl) × insulin (mcU/ml) /405 (see Matthews et al., 1985, for description)⁴⁴