Effects of Exenatide on Hypothalamic Obesity

Hypothalamic Obesity Clinical Trial

Official title:

Effects of Exenatide on Hypothalamic Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061775
• Other study ID #: 0903-028
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2010
• Est. completion date: March 15, 2019

Study information

• Verified date: September 2019
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 15, 2019
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothalamic Obesity
• Obesity

Intervention

Drug:
• Exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Locations

Country	Name	City	State
United States	Children's Hospital of Orange County	Orange	California
United States	Children's Hospitals & Clincis of Minnesota	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI Change	BMI was collected at baseline and 24 weeks	24 weeks
Primary	Waist to Height Ratio (WHtR)	Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks	24 weeks
Secondary	Childhood Eating Behavior Questionnaire (CEBQ)	The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.	24 weeks
Secondary	Calorie Intake Based on 3-day Diet Records	Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.	24 weeks

External Links

•   Hospital website