title: Long-acting Insulin Analogs Effect on gh/igf Axis of Children with Type 1 Diabetes: a Randomized, Open-label, Two-period, Cross-over Trial.
abstract: BACKGROUND
  Growth hormone (GH) secretion is increased in pre-pubertal children with type 1 diabetes and GH excess produces insulin resistance. Early-morning insulinopenia contributes to lower insulin-like growth factor (IGF-I) levels and to GH hypersecretion.
  
  
  OBJECTIVE
  To evaluate differences in GH/IGF-I axis of pre-pubertal children with type 1 diabetes treated with glargine or detemir as long-acting insulin analogues, which was the main outcome measure, and to compare insulin effects in obtaining good metabolic control.
  
  
  METHODS
  Children with type 1 diabetes.
  
  
  METHODS
  This was a 32-week, randomized, open-label, two-period, cross-over comparison between bedtime glargine and twice-daily detemir insulin, involving pre-pubertal children in care at a diabetes pediatric centre. After a 8-week-run-in period subjects were randomized to bedtime glargine or twice-daily detemir insulin administration. After a 12-week period treatments were inverted and continued for additional 12 weeks.
  
  
  RESULTS
  Overall, 15 pre-pubertal children (53.3% males, mean age 8.6±1.5 years, duration of diabetes 4.2±1.5 years) completed the study. Groups did not differ for GH/IGF axis and HbA1c levels. Treatment with glargine was associated with lower fasting glucose values than treatment with detemir (8.1±1.5 vs. 8.2±1.7 mmol/L, p=0.01). Incidence rate of hypoglycemia was not different between insulin treatments (IRR=1.18, 95%CI 1.00-1.38; p=0.07). Detemir treatment was associated with a higher increase in body weight (p=0.008) and height (p=0.02) when compared with glargine.
  
  
  CONCLUSIONS
  Detemir and glargine not show significant differential effects on the GH/IGFI axis. The greater weight gain and height associated with detemir treatment, apparently not related to the level of pubertal growth, deserve further investigation.
authors.affiliation: Department of Women's and Children's Health, Salesi Hospital, Ancona, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Cherubini
authors.affiliation: SSD Diabetologia, Ospedale Niguarda Ca' Granda, Milan, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Pintaudi
authors.affiliation: Department of Women's and Children's Health, Salesi Hospital, Ancona, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Iannilli
authors.affiliation: Department of Pediatrics, Bartolomeo Eustachio Hospital, Macerata, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Pambianchi
authors.affiliation: Department of Women's and Children's Health, Salesi Hospital, Ancona, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Ferrito
authors.affiliation: Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Nicolucci
mesh_terms: D002648:Child; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D019382:Human Growth Hormone / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D000069057:Insulin Detemir / Q000008:administration & dosage / Q000494:pharmacology*; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000494:pharmacology*; D007334:Insulin-Like Growth Factor I / Q000378:metabolism*; D008297:Male; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; C583557:IGF1 protein, human; D019382:Human Growth Hormone; D000069036:Insulin Glargine; D000069057:Insulin Detemir; D007334:Insulin-Like Growth Factor I