Effects of Exenatide on Hypothalamic Obesity
|ClinicalTrials.gov Identifier: NCT01061775|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2010
Results First Posted : March 21, 2016
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypothalamic Obesity||Drug: Exenatide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Exenatide on Hypothalamic Obesity|
|Study Start Date :||January 2010|
|Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||December 2017|
5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
Other Name: Byetta
- BMI Change [ Time Frame: 24 weeks ]BMI was collected at baseline and 24 weeks
- Waist to Height Ratio (WHtR) [ Time Frame: 24 weeks ]Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks
- Childhood Eating Behavior Questionnaire (CEBQ) [ Time Frame: 24 weeks ]The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.
- Calorie Intake Based on 3-day Diet Records [ Time Frame: 24 weeks ]Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061775
|United States, California|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|United States, Minnesota|
|Children's Hospitals & Clincis of Minnesota|
|Saint Paul, Minnesota, United States, 55102|
|Principal Investigator:||M. Jennifer Abuzzahab, MD||Children's Hospitals & Clinics of Minnesota|