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Effects of recombinant human growth hormone in anorexia nervosa: a randomized, placebo-controlled study.

Author(s): Fazeli PK, Lawson EA, Prabhakaran R, Miller KK, Donoho DA, Clemmons DR, Herzog DB, Misra M, Klibanski A

Affiliation(s): Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts 02114, USA.

Publication date & source: 2010-11, J Clin Endocrinol Metab., 95(11):4889-97. Epub 2010 Jul 28.

Publication type: Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

CONTEXT: Anorexia nervosa (AN), a state of chronic nutritional deprivation, is characterized by GH resistance with elevated GH levels and decreased levels of IGF-I. The effects of supraphysiological recombinant human GH (rhGH) on GH resistance in AN are not currently known. OBJECTIVE: The aim was to investigate whether supraphysiological rhGH increases IGF-I levels in AN. DESIGN AND SETTING: We conducted a randomized, placebo-controlled study in a Clinical Research Center. PATIENTS: We studied 21 women with AN, 10 (mean age, 28 +/- 2.1 yr) treated with rhGH and 11 (mean age, 29.2 +/- 2.6 yr) treated with placebo. INTERVENTIONS: rhGH (mean maximum daily dose, 1.4 +/- 0.12 mg/d) or placebo was administered to patients for 12 wk. MAIN OUTCOME MEASURES: IGF-I, N-terminal propeptide of type 1 procollagen, type I collagen C-telopeptide, glucose, and insulin levels were measured at wk 0, 1, 2, 3, 4, 8, and 12; C-terminal propeptide of type 1 procollagen, leptin, and free fatty acid levels were measured at wk 0 and 12. Body composition, including total fat and lean mass, was measured by dual-energy x-ray absorptiometry at wk 0 and 12. RESULTS: IGF-I levels did not differ between the groups at baseline or after treatment (median after 12 wk-rhGH, 124 ng/ml, interquartile range, 94.5, 170.3; vs. placebo, 85.5 ng/ml, interquartile range, 62, 139; P = 0.3). Similarly, changes in glucose, insulin, free fatty acids, and bone markers did not differ between the groups. Total fat mass and percentage fat mass (rhGH, -2.5 +/- 0.6%, vs. placebo, 2.2 +/- 1.1%; P = 0.004) decreased significantly in the rhGH group compared to placebo despite comparable weight. CONCLUSIONS: Supraphysiological rhGH administration decreases fat mass in AN without increasing IGF-I levels, supporting the role of GH as a mediator of lipolysis independent of IGF-I.

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