Hypothalamic Obesity Clinical Trial
Official title:
Effects of Exenatide on Hypothalamic Obesity
Verified date | September 2019 |
Source | Children's Hospitals and Clinics of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.
Status | Completed |
Enrollment | 19 |
Est. completion date | March 15, 2019 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 21 Years |
Eligibility |
Inclusion Criteria: - >/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors - 10-21 years old - Age-and sex-adjusted BMI >/=95% - Parent sign consent and patient sign assent Exclusion Criteria: - < 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors - Pregnant or breastfeeding, or those women who plan to get pregnant - Renal impairment - Gastroparesis - Pancreatitis - Diabetes - <1 month post initiation of Metformin treatment - Prescription or over-the-counter weight loss medications within 3 months of screening - Are actively participating in, or have participated in a formal weight loss program within the last 3 months - Have had bariatric surgery |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospitals & Clincis of Minnesota | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota | Amylin Pharmaceuticals, LLC. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BMI Change | BMI was collected at baseline and 24 weeks | 24 weeks | |
Primary | Waist to Height Ratio (WHtR) | Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks | 24 weeks | |
Secondary | Childhood Eating Behavior Questionnaire (CEBQ) | 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. | 24 weeks | |
Secondary | Calorie Intake Based on 3-day Diet Records | 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. | 24 weeks |
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