title: Effect of growth hormone treatment on trunk fat accumulation in adult GH-deficient Japanese patients: a randomised, placebo-controlled trial.
abstract: OBJECTIVE
  Patients with growth hormone deficiency (GHD), both Japanese and Caucasian, have an abnormal body composition with pronounced abdominal obesity. This study aimed to evaluate changes in trunk fat with GH treatment.
  
  
  METHODS
  Double-blind, placebo-controlled study.
  
  
  METHODS
  Sixty-one Japanese adult GH deficient patients (mean age 37 years) were randomised to either GH, titrated to 0.012 mg/kg/day, (n = 30) or placebo (n = 31) for 24 weeks. Body composition, by dual-energy X-ray absorptiometry (DXA), was evaluated at a central laboratory for trunk fat, total body fat and lean body mass. Serum lipid levels were also determined centrally.
  
  
  RESULTS
  At baseline, 26 (42.6%) patients had a body mass index (BMI) > or = 25 kg/m(2), the threshold for obesity-related complications for Japanese subjects. Median trunk fat mass (FM) was > or = 9.0 kg for each treatment and gender group, higher than the cut-off for increased age-adjusted risk for cardiovascular complications reported in the normal Japanese population. After 24 weeks of GH treatment, the change in percentage trunk FM was -3.4 +/- 0.6%, versus 0.4 +/- 0.6% with placebo (p < 0.001). Change in total body FM was -2.8 +/- 0.5% with GH and 0.0 +/- 0.5% with placebo, indicating that the decrease in trunk fat was more pronounced than for total body fat. Total and low density lipoprotein (LDL)-cholesterol were both significantly (p < 0.001) decreased compared with placebo. One patient discontinued due to a subdural haematoma and one had GH dose reduced due to hyperglycaemia.
  
  
  CONCLUSIONS
  Japanese patients with GHD have abnormal central fat accumulation, which is reduced by GH treatment over 24 weeks. This may reduce cardiovascular risk but the GH dose should be individualised to maintain IGF-I in the normal range.
authors.affiliation: Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. chiharak@med.kobe-u.ac.jp
authors.forename: Kazuo
authors.initials: K
authors.lastname: Chihara
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Kato
authors.forename: Kazue
authors.initials: K
authors.lastname: Takano
authors.forename: Akira
authors.initials: A
authors.lastname: Shimatsu
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kohno
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Tanaka
authors.forename: Minoru
authors.initials: M
authors.lastname: Irie
mesh_terms: D050153:Abdominal Fat; D000328:Adult; D044466:Asian People; D001823:Body Composition; D004311:Double-Blind Method; D005260:Female; D006130:Growth Disorders / Q000097:blood / Q000188:drug therapy; D019382:Human Growth Hormone / Q000172:deficiency* / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged
chemical_list: D008055:Lipids; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I