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Effects of Recombinant Growth Hormone on Visceral Fat Accumulation: Pilot Study in Human Immunodeficiency Virus-Infected Adolescents

Department of Paediatrics (A.V., P.M., L.S., S.B., B.d.N., P.B.), L. Sacco Hospital, University of Milan, 20157 Milan, Italy; Laboratory of Paediatric Endocrinology (S.M.), Istituto di Ricovero e Cura a Carattere Scientifico, HS. Raffaele, 20132 Milan, Italy; and Department of Pharmacology (M.M.), Istituto di Ricovero e Cura a Carattere Scientifico, S. Matteo Hospital, 27100 Pavia, Italy

Address all correspondence and requests for reprints to: Dr. Alessandra Viganò, Cattedra di Pediatria, Ospedale L. Sacco, via GB Grassi 74, 20157 Milano, Italy. E-mail: alessandra.vigano{at}unimi.it.

Context: Recombinant human GH (rhGH) reduces excess accumulation of intraabdominal adipose tissue (IAT) in lipodystrophic HIV-infected adults, whereas data in pediatric patients are lacking.

Objective: The objective of this study was to assess the efficacy of rhGH treatment on lipodystrophy in HIV-infected adolescents.

Design: The study is a prospective, 24-wk open-label study of rhGH.

Setting: The study was conducted at a referral center for pediatric HIV infection.

Patients and Other Participants: Eight HIV-infected adolescents (ages, 13.7–18.5 yr), with abnormal IAT accumulation (>41 cm² at L4-magnetic resonance imaging) and 97 healthy controls (HC) (ages, 9.5–19.9 yr) were enrolled.

Intervention: rhGH was given by sc injection at a daily dose of 0.028 mg/kg.

Main Outcome Measures: The main outcome was change in IAT at L4-magnetic resonance imaging. Body composition by dual-energy x-ray absorptiometry, glucose and lipid metabolism, and IGF-I changes were also evaluated.

Results: All patients completed the study period; none of them showed adverse event, and no change in the daily dose of rhGH was required. The treatment was associated with a mean height increase of 2.4 cm. From baseline to wk 24, IAT area decreased significantly by a median of 34.5% (–19.2 to –70%). Fat mass decreased significantly in patients, compared with HC, with a median loss of total, trunk, and arm and leg fat mass of 10.4, 10.9, 12.7, and 5.4%, respectively. Total, arm, and leg lean masses increased significantly, compared with HC. IGF-I increased significantly, but supraphysiological values of mild degree (2–23% over the upper normal limit) were detected in only nine of 24 samples. No significant effects on glucose metabolism, triglyceride, and cholesterol levels were observed.

Conclusions: Our data showed that rhGH 0.028 mg/kg daily for 24 wk in HIV-infected adolescents reduces IAT, trunk, and also limb fat and increases lean mass. Overall, short-term rhGH is well tolerated and is not associated with a worsening of glucose and lipid metabolism.

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