title: Effects of recombinant human growth hormone in anorexia nervosa: a randomized, placebo-controlled study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  We conducted a randomized, placebo-controlled study in a Clinical Research Center.
  
  
  METHODS
  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.
  
  
  METHODS
  rhGH (mean maximum daily dose, 1.4 ± 0.12 mg/d) or placebo was administered to patients for 12 wk.
  
  
  METHODS
  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.
authors.affiliation: Neuroendocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts 02114, USA.
authors.forename: Pouneh K
authors.initials: PK
authors.lastname: Fazeli
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Lawson
authors.forename: Rajani
authors.initials: R
authors.lastname: Prabhakaran
authors.forename: Karen K
authors.initials: KK
authors.lastname: Miller
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Donoho
authors.forename: David R
authors.initials: DR
authors.lastname: Clemmons
authors.forename: David B
authors.initials: DB
authors.lastname: Herzog
authors.forename: Madhusmita
authors.initials: M
authors.lastname: Misra
authors.forename: Anne
authors.initials: A
authors.lastname: Klibanski
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D000704:Analysis of Variance; D000856:Anorexia Nervosa / Q000097:blood / Q000628:therapy*; D001786:Blood Glucose / Q000378:metabolism; D001823:Body Composition; D024042:Collagen Type I / Q000097:blood; D005260:Female; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D007328:Insulin / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000378:metabolism*; D020738:Leptin / Q000097:blood; D011863:Radioimmunoassay; D011994:Recombinant Proteins / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D024042:Collagen Type I; D007328:Insulin; D020738:Leptin; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I