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NCT Number: NCT01061775

Effects of Exenatide on Hypothalamic Obesity

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.

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Key information

Conditions

Hypothalamic Obesity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniopharyngioma Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Gonadal Dysgenesis Hypogonadism Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Sexual Infantilism Urogenital Abnormalities Urogenital Diseases

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Hospital of Orange County, Orange, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Other names: Byetta

Primary outcomes

  1. BMI Change

    Time frame: 24 weeks

    BMI was collected at baseline and 24 weeks

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2019
First posted
Feb 3, 2010
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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