title: The addition of rosiglitazone to insulin in adolescents with type 1 diabetes and poor glycaemic control: a randomized-controlled trial.
abstract: OBJECTIVE
  To evaluate the effect of rosiglitazone, an insulin sensitizer, on glycaemic control and insulin resistance in adolescents with type 1 diabetes mellitus (T1DM) RESEARCH DESIGN AND METHODS: Randomized, double-blind, placebo-controlled crossover trial of rosiglitazone (4 mg twice daily) vs. placebo (24 wk each, with a 4 wk washout period). Entry criteria were diabetes duration >1 yr, age 10-18 yr, puberty (>or=Tanner breast stage 2 or testicular volume >4 mL), insulin dose >or=1.1 units/kg/day, and haemoglobin A1c (HbA1c) >8%. Responses to rosiglitazone were compared with placebo using paired t-tests.
  
  
  RESULTS
  Of 36 adolescents recruited (17 males), 28 completed the trial. At baseline, age was 13.6 +/- 1.8 yr, HbA1c 8.9 +/- 0.96%, body mass index standard deviation scores (BMI-SDS) 0.94 +/- 0.74 and insulin dose 1.5 +/- 0.3 units/kg/day. Compared with placebo, rosiglitazone resulted in decreased insulin dose (5.8% decrease vs. 9.4% increase, p = 0.02), increased serum adiponectin (84.8% increase vs. 26.0% decrease, p < 0.01), increased cholesterol (+0.5 mmol/L vs. no change, p = 0.02), but no significant change in HbA1c (-0.3 vs. -0.1, p = 0.57) or BMI-SDS (0.08 vs. 0.04, p = 0.31). Insulin sensitivity was highly variable in the seven subjects who consented to euglycaemic hyperinsulinaemic clamps. There were no major adverse effects attributable to rosiglitazone.
  
  
  CONCLUSIONS
  The addition of rosiglitazone to insulin did not improve HbA1c in this group of normal weight adolescents with T1DM.
authors.affiliation: Department of Endocrinology, Sydney Children's Hospital, Randwick, New South Wales, Australia. stonem@med.usyd.edu.au
authors.forename: Monique L
authors.initials: ML
authors.lastname: Stone
authors.forename: Jan L
authors.initials: JL
authors.lastname: Walker
authors.forename: Donald
authors.initials: D
authors.lastname: Chisholm
authors.forename: Maria E
authors.initials: ME
authors.lastname: Craig
authors.forename: Kim C
authors.initials: KC
authors.lastname: Donaghue
authors.forename: Patricia
authors.initials: P
authors.lastname: Crock
authors.forename: Donald
authors.initials: D
authors.lastname: Anderson
authors.forename: Charles F
authors.initials: CF
authors.lastname: Verge
mesh_terms: D052242:Adiponectin / Q000097:blood; D000293:Adolescent; D001786:Blood Glucose / Q000378:metabolism*; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007333:Insulin Resistance; D008297:Male; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D052242:Adiponectin; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000077154:Rosiglitazone; D045162:Thiazolidinediones