Clinical trial NCT01061775: Effects of Exenatide on Hypothalamic Obesity
Official title: Effects of Exenatide on Hypothalamic Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypothalamic Obesity
Keywords: Hypothalamic Obesity
Exenatide
Byetta
Craniopharyngioma
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2010-02-03
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the glucagon-like peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite.

Eligibility criteria: 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

Primary outcomes:
measure: BMI Change
timeFrame: 24 weeks
measure: Waist to Height Ratio (WHtR)
timeFrame: 24 weeks
Secondary outcomes:
measure: Childhood Eating Behavior Questionnaire (CEBQ)
timeFrame: 24 weeks
measure: Calorie Intake Based on 3-day Diet Records
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Saint Paul
country: United States
facility: Children's Hospitals & Clincis of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals & Clinics of Minnesota
name: M. Jennifer Abuzzahab, MD
role: PRINCIPAL_INVESTIGATOR
References: