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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: December 19, 2013
Last verified: December 2013
  Purpose

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.


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:
  • Change in age- and sex-adjusted BMI. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 19
Study Start Date: January 2010
Estimated Study Completion Date: February 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide Drug: Exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

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 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
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, 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:
No publications provided

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
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014