Effects of Exenatide on Hypothalamic Obesity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2019-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypothalamic Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide

5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Interventions

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Exenatide

5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Intervention Type DRUG

Other Intervention Names

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Byetta

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No