Effects of Exenatide on Hypothalamic Obesity

Children's Hospitals and Clinics of Minnesota

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypothalamic Obesity

Treatments: Drug: Exenatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01061775

0903-028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Exenatide

Experimental group

Description:

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

Treatment:

Drug: Exenatide