Effects of Exenatide on Hypothalamic Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- BMI Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/=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
排除标准
- •< 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
- •<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
研究组 & 干预措施
Exenatide
5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
干预措施: Exenatide (Drug)
结局指标
主要结局
BMI Change
时间窗: 24 weeks
BMI was collected at baseline and 24 weeks
Waist to Height Ratio (WHtR)
时间窗: 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
次要结局
- Childhood Eating Behavior Questionnaire (CEBQ)(24 weeks)
- Calorie Intake Based on 3-day Diet Records(24 weeks)