Effects of Exenatide on Hypothalamic Obesity
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 21 |
| Updated: | 4/21/2016 |
| Start Date: | January 2010 |
| End Date: | December 2016 |
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.
(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.
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.
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.
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
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