Overview

This trial is active, not recruiting.

Condition hypothalamic obesity
Treatment exenatide
Phase phase 1/phase 2
Sponsor Children's Hospitals and Clinics of Minnesota
Collaborator Amylin Pharmaceuticals, LLC.
Start date January 2010
End date July 2013
Trial size 19 participants
Trial identifier NCT01061775, 0903-028

Summary

The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index [BMI]) 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 BMI significantly from baseline.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Primary Outcomes

Measure
Change in age- and sex-adjusted BMI.
time frame: 6 months

Eligibility Criteria

Male or female participants from 10 years up to 21 years old.

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

Additional Information

Official title Effects of Exenatide on Hypothalamic Obesity
Principal investigator M. Jennifer Abuzzahab, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota.