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The addition of rosiglitazone to insulin in adolescents with type 1 diabetes and poor glycaemic control: a randomized‐controlled trial
Author(s) -
Stone Monique L,
Walker Jan L,
Chisholm Donald,
Craig Maria E,
Donaghue Kim C,
Crock Patricia,
Anderson Donald,
Verge Charles F
Publication year - 2008
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/j.1399-5448.2008.00383.x
Subject(s) - medicine , rosiglitazone , endocrinology , placebo , insulin , crossover study , diabetes mellitus , body mass index , type 1 diabetes , type 2 diabetes , pathology , alternative medicine
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 (≥Tanner breast stage 2 or testicular volume >4 mL), insulin dose ≥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. Conclusion: The addition of rosiglitazone to insulin did not improve HbA1c in this group of normal weight adolescents with T1DM.