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Departments of Pediatrics (A.M.H., R.H.J., R.G.R., S.H.L.) and Internal Medicine (D.D.S., J.Q.P.), Oregon Health and Science University, Portland, Oregon 97201
Address all correspondence and requests for reprints to: Andrea M. Haqq, M.D., Department of Pediatrics, Division of Endocrinology and Diabetes, Duke University Medical Center, 306FA Bell Building, Box 3080, Durham, North Carolina 27710. E-mail: haqq0001{at}mc.duke.edu.
The objective of this study was to investigate the effects of GH administration on pulmonary function, sleep, behavior, cognition, linear growth velocity, body composition, and resting energy expenditure (REE) in children with Prader-Willi syndrome. The study used a 12-month, balanced, randomized, double-blind, placebo-controlled, cross-over experimental design. Twelve subjects were randomized to GH (0.043 mg/kg·d) or placebo intervention for 6 months and then crossed over to the alternate intervention for 6 months. Differences in outcome variables were determined by paired t tests. Peak flow rate, percentage vital capacity, and forced expiratory flow rate improved and number of hypopnea and apnea events and duration of apnea events trended toward improvement after GH intervention. The only difference in cognition or behavior was an increase in hyperactivity scale on the Behavior Assessment System for Children after GH intervention. Linear growth velocity, REE, and lean mass were higher (67%, 19%, and 7.6%, respectively), and fat mass and percentage body fat were lower (10.3% and 8.1%, respectively) after GH intervention. GH administration did not change mean fasting ghrelin concentration. GH intervention improved body composition and REE and may contribute to better sleep quality and pulmonary function. GH administration did not impact fasting ghrelin concentration.
This work was supported by grants from the General Clinical Research Center NIH/NCRR (M01-RR-00334), Pharmacia Corp. (to A.M.H., S.H.L., and R.G.R.), and NIH (K-23-DK-02689, to J.Q.P.).
Abbreviations: BASC, Behavior Assessment System for Children; BMC, bone mineral content; BMD, bone mineral density; BMI, body mass index; CBCL, Child Behavior Checklist; FEF25–75, forced expiratory flow rate; FEV1, forced expiratory volume expired in 1 sec; FM, fat mass; FT4, free T4; GHD, GH deficiency; IGFBP, IGF-binding protein; IRMA, immunoradiometric assay; IQ, Intelligence quotient; LM, lean mass; PFR, peak flow rate; PWS, Prader Willi syndrome; REE, resting energy expenditure; SDS, SD score; VC, vital capacity.
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