| dc.contributor |
Elena Volpi |
|
| dc.contributor |
Rubina Heptulla |
|
| dc.contributor |
Antonella Casola |
|
| dc.contributor |
Melinda Sheffield -Moore |
|
| dc.creator |
Withycombe , Sarah Elizabeth |
|
| dc.date |
2010 -09 -28 |
|
| dc.date.accessioned |
2011 -04 -27T21 :40 :59Z |
|
| dc.date.available |
2011 -04 -27T21 :40 :59Z |
|
| dc.date.issued |
2011 -04 -27T21 :40 :59Z |
|
| dc.identifier |
http : / /etd .utmb .edu /theses /available /etd -07282010 -230410 / |
|
| dc.identifier.uri |
http : / /hdl .handle .net /2249 .1 /35879 |
|
| dc.description |
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 Childrens Hospitals 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
done using two -sample t -tests assuming equal variance and paired two -sample t -tests performed in Excel . No statistical differences in ΔHbA1C or Δ1 ,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 . |
|
| dc.format |
application /pdf |
|
| dc.language |
en |
|
| dc.publisher |
UTMB |
|
| dc.rights |
restricted |
|
| dc.rights |
I hereby certify that , if appropriate , I have obtained and attached hereto a written permission statement from the owner (s ) of each third party copyrighted matter to be included in my thesis , dissertation , or project report , allowing distribution as specified below . I certify that the version I submitted is the same as that approved by my advisory committee . I hereby grant to University of Texas Medical Branch or its agents the non -exclusive license to archive and make accessible , under the conditions specified below , my thesis , dissertation , or project report in whole or in part in all forms of media , now or hereafter known . I retain all other ownership rights to the copyright of the thesis , dissertation or project report . I also retain the right to use in future works (such as articles or books ) all or part of this thesis , dissertation , or project report . |
|
| dc.source |
http : / /etd .utmb .edu /theses /available /etd -07282010 -230410 / |
|
| dc.subject |
Preventative Medicine and Community Health |
|
| 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 |
|
| dc.type |
text |
|