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| Sponsor: | Children's Hospitals and Clinics of Minnesota |
|---|---|
| Collaborator: |
Amylin Pharmaceuticals, Inc. |
| Information provided by: | Children's Hospitals and Clinics of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01061775 |
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 I Phase II |
| 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 |
| Estimated Enrollment: | 19 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Houa Vue, Ph.D. | 651-220-6219 | houa.vue@childrensmn.org |
| United States, Minnesota | |
| Children's Hospitals & Clincis of Minnesota | Recruiting |
| St. Paul, Minnesota, United States, 55102 | |
| Contact: Houa Vue, Ph.D 651-220-6219 houa.vue@childrensmn.org | |
| Principal Investigator: M. Jennifer Abuzzahab, MD | |
| Sub-Investigator: Jennifer Kyllo, MD | |
| Sub-Investigator: Laura Gandrud, MD | |
| Sub-Investigator: Chistine Ternand, MD | |
| Sub-Investigator: Costa Voulgaropoulos, MD | |
| Principal Investigator: | M. Jennifer Abuzzahab, MD | Children's Hospitals & Clinics of Minnesota |
More Information
| Responsible Party: | Jennifer Abuzzahab, MD, 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: | June 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypothalamic Obesity Exenatide Byetta Craniopharyngioma |
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
