Effects of Exenatide on Hypothalamic Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|