A 4-month randomized controlled clinical trial of adjuvant exenatide or pramlintide versus insulin alone in pediatric type 1 diabetes mellitus: Effect on glycemic control

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dc.contributor.advisor Elena Volpi en_US
dc.contributor.committeeMember Melinda Sheffield -Moore en_US
dc.contributor.committeeMember Antonella Casola en_US
dc.creator Sarah Elizabeth Withycombe en_US
dc.date.accessioned 2011 -12 -20T16 :05 :07Z
dc.date.accessioned 2014 -02 -19T22 :05 :27Z
dc.date.available 2010 -09 -28 en_US
dc.date.available 2011 -12 -20T16 :05 :07Z
dc.date.available 2014 -02 -19T22 :05 :27Z
dc.date.created 2010 -07 -28 en_US
dc.date.issued 2010 -07 -29 en_US
dc.identifier.other etd -07282010 -230410 en_US
dc.identifier.uri http : / /hdl .handle .net /2152 .3 /197
dc.description.abstract This study investigates the effects of 16 weeks of treatment with adjuvant Exenatide or Pramlintide versus insulin alone on glycemic control , as measured by glycated hemoglobin (HbA1C ) and 1 ,5 -Anhydroglucitol (1 ,5 -AG ) , or GlycoMark , in pediatric Type 1 Diabetes Mellitus (T1DM ) . We present here the preliminary results (n=24 ) of a Phase III randomized clinical trial designed to compare the glycemic effects of using adjuvant Pramlintide or Exenatide versus insulin alone in pediatric T1DM . Sample size calculations estimated 21 patients per treatment arm (63 total ) are needed . So far , 24 patients have been recruited from Texas Children’s Hospital’s main Diabetes Care Center or its outlying clinics in the Houston , TX area . Recruited patients were randomized to one of 3 treatment arms (Pramlintide + insulin , Exenatide + insulin , or insulin alone ) and completed 16 weeks of treatment . HbA1C and 1 ,5 -AG levels were the primary endpoints analyzed as measures of glycemic control . All statistical analyses were \r \ndone using two -sample t -tests assuming equal variance and paired two -sample t -tests performed in Excel . No statistical differences in & #916 ;HbA1C or & #916 ;1 ,5 -AG were observed between each treatment arm and the insulin control arm . Similarly , no statistical differences in HbA1C or 1 ,5 -AG were reported within each group from baseline to 16 weeks . These preliminary data suggest that addition of Pramlintide or Exenatide to insulin regimen of pediatric T1DM does not improve glycemic control . However , reevaluation of the results upon study completion is warranted . en_US
dc.format.medium electronic en_US
dc.language.iso eng en_US
dc.rights Copyright © is held by the author . Presentation of this material on the TDL web site by The University of Texas Medical Branch at Galveston was made possible under a limited license grant from the author who has retained all copyrights in the works . en_US
dc.subject symlin en_US
dc.subject HbA1C en_US
dc.subject glycomark en_US
dc.subject glycated hemoglobin en_US
dc.subject byetta en_US
dc.title A 4 -month randomized controlled clinical trial of adjuvant exenatide or pramlintide versus insulin alone in pediatric type 1 diabetes mellitus : Effect on glycemic control en_US
dc.type.genre thesis en_US
dc.type.material text en_US
thesis.degree.name Master of Science en_US
thesis.degree.level Master en_US
thesis.degree.grantor The University of Texas Medical Branch en_US
thesis.degree.department Preventative Medicine and Community Health en_US

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A 4-month randomized controlled clinical trial of adjuvant exenatide or pramlintide versus insulin alone in pediatric type 1 diabetes mellitus: Effect on glycemic control. The University of Texas Medical Branch. Available electronically from http : / /hdl .handle .net /2152 .3 /197 .

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