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Effects of Exenatide on Hypothalamic Obesity

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ClinicalTrials.gov Identifier: NCT01061775
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : March 21, 2016
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

Tracking Information
First Submitted Date  ICMJE February 2, 2010
First Posted Date  ICMJE February 3, 2010
Results First Submitted Date  ICMJE February 25, 2015
Results First Posted Date  ICMJE March 21, 2016
Last Update Posted Date October 8, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
  • BMI Change [ Time Frame: 24 weeks ]
    BMI was collected at baseline and 24 weeks
  • Waist to Height Ratio (WHtR) [ Time Frame: 24 weeks ]
    Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2010)
Change in age- and sex-adjusted BMI. [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01061775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2016)
  • Childhood Eating Behavior Questionnaire (CEBQ) [ Time Frame: 24 weeks ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Exenatide on Hypothalamic Obesity
Official Title  ICMJE Effects of Exenatide on Hypothalamic Obesity
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypothalamic Obesity
Intervention  ICMJE Drug: Exenatide
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
Other Name: Byetta
Study Arms  ICMJE 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.
Intervention: Drug: Exenatide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2010)
19
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2019
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01061775
Other Study ID Numbers  ICMJE 0903-028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data.
Responsible Party Children's Hospitals and Clinics of Minnesota
Study Sponsor  ICMJE Children's Hospitals and Clinics of Minnesota
Collaborators  ICMJE Amylin Pharmaceuticals, LLC.
Investigators  ICMJE
Principal Investigator: M. Jennifer Abuzzahab, MD Children's Hospitals & Clinics of Minnesota
PRS Account Children's Hospitals and Clinics of Minnesota
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP