title: Randomized GH trial with two different dosages in combination with a GnRH analogue in short small for gestational age children: effects on metabolic profile and serum GH, IGF1, and IGFBP3 levels.
abstract: BACKGROUND
  GnRH analogue (GnRHa) combined with GH treatment has been proposed to increase adult height. Effect on metabolic profile and GH, IGF1, and IGFBP3 levels in short small for gestational age (SGA) children is unknown.
  
  
  OBJECTIVE
  To assess fat mass and lean body mass SDS, percentage trunk fat, blood pressure (BP), insulin sensitivity (Si), beta-cell function (disposition index, DI), lipid profile, and GH, IGF1, and IGFBP3 levels during 2 years of combined treatment.
  
  
  METHODS
  Forty-one pubertal short SGA children with a mean (+/-S.D.) age of 12.1 (+/-1.0) years.
  
  
  METHODS
  Children received 3.75 mg of leuprolide acetate depot subcutaneously every 4 weeks, and they were randomly assigned to receive 1 mg (group A) or 2 mg (group B) of GH/m(2) per day.
  
  
  RESULTS
  Percentage trunk fat increased in both groups, but to a lower extent in group B. Lean body mass SDS increased only in group B. Changes in BP, Si, DI, and lipids were similar in both groups. Si significantly decreased, but DI remained unchanged. Lipids remained normal. GH and IGF1 levels were significantly higher in group B.
  
  
  CONCLUSIONS
  Our study is the first to report that 2 years of combined treatment with a GnRHa and either 1 or 2 mg GH/m(2) per day does not adversely affect body composition and metabolic profile of short SGA children who come under medical attention at the onset of puberty. There was a dose-dependent effect on fat mass SDS(height), percentage trunk fat, lean body mass SDS(height), and GH and IGF1 levels in favor of treatment with GnRHa and the higher GH dose of 2 mg/m(2) per day.
authors.affiliation: Division of Endocrinology, Department of Pediatrics, Erasmus Medical Center, Rotterdam, The Netherlands. d.vanderkaay@erasmusmc.nl
authors.forename: Daniëlle
authors.initials: D
authors.lastname: van der Kaay
authors.forename: Boudewijn
authors.initials: B
authors.lastname: Bakker
authors.forename: Flip
authors.initials: F
authors.lastname: van der Hulst
authors.forename: Dick
authors.initials: D
authors.lastname: Mul
authors.forename: Jaap
authors.initials: J
authors.lastname: Mulder
authors.forename: Eelco
authors.initials: E
authors.lastname: Schroor
authors.forename: Denise
authors.initials: D
authors.lastname: van Elswijk
authors.forename: Inge
authors.initials: I
authors.lastname: Rowaan
authors.forename: Merel
authors.initials: M
authors.lastname: Willeboer
authors.forename: Maria
authors.initials: M
authors.lastname: de Ridder
authors.forename: Anita
authors.initials: A
authors.lastname: Hokken-Koelega
mesh_terms: D000273:Adipose Tissue / Q000187:drug effects; D000293:Adolescent; D001794:Blood Pressure / Q000187:drug effects; D001823:Body Composition / Q000187:drug effects; D002648:Child; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007236:Infant, Small for Gestational Age; D007333:Insulin Resistance; D018972:Insulin-Like Growth Factor Binding Protein 3; D018969:Insulin-Like Growth Factor Binding Proteins / Q000097:blood*; D007334:Insulin-Like Growth Factor I / Q000378:metabolism*; D016729:Leuprolide / Q000627:therapeutic use*; D008297:Male
chemical_list: C515497:IGFBP3 protein, human; D018972:Insulin-Like Growth Factor Binding Protein 3; D018969:Insulin-Like Growth Factor Binding Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; D016729:Leuprolide