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Effects of Exenatide on Hypothalamic Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01061775
First received: February 2, 2010
Last updated: February 22, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Hypothalamic Obesity
Drug: Exenatide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exenatide on Hypothalamic Obesity

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • BMI Change [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    BMI was collected at baseline and 24 weeks

  • Waist to Height Ratio (WHtR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks


Secondary Outcome Measures:
  • Childhood Eating Behavior Questionnaire (CEBQ) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Calorie Intake Based on 3-day Diet Records [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide
5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
Drug: Exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
Other Name: Byetta

Detailed 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.
  Eligibility

Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061775

Locations
United States, California
Children's Hospital of Orange County
Orange County, California, United States, 92868
United States, Minnesota
Children's Hospitals & Clincis of Minnesota
St. Paul, Minnesota, United States, 55102
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: M. Jennifer Abuzzahab, MD Children's Hospitals & Clinics of Minnesota
  More Information

Additional Information:
Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01061775     History of Changes
Other Study ID Numbers: 0903-028 
Study First Received: February 2, 2010
Results First Received: February 25, 2015
Last Updated: February 22, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data.

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Hypothalamic Obesity
Exenatide
Byetta
Craniopharyngioma

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016