Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Hypothalamic gliosis
研究概览
简要总结
BEAM is a multi-site longitudinal cohort study of hypothalamic gliosis, central regulation of appetite and weight gain in children. Participants will be recruited from the community in the greater Seattle and greater Baltimore area. All participants will consent to enroll in the 24-month study during which they will complete 5 in-person study visits.
详细描述
The proposed 2-site research study uses a longitudinal cohort design in 102 children aged 9-11 yr. It will include for all participants baseline MRI and functional MRI, in-depth eating behavior testing, and measurement of hormone profiles. Serial measurement of weight and self-reported eating habits will occur over 2 yr, with a repeated MRI at 2 yr. The study aims to: 1) test if MBH gliosis is associated with impaired intake regulation and poor weight outcomes over 2 yr in children, 2) determine if CNS appetitive processing is negatively affected when evidence of MBH gliosis is present, and 3) test for other brain regions in which gliosis is present in association with excess adiposity in children. An exploratory aim will assess changes in gliosis in children over 2 yr and their relation to changes in body weight and adiposity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •9-11 y (at time of enrollment)
- •BMI ≥ 15th percentile for age and sex
排除标准
- •Significant Health conditions (e.g., type 2 diabetes)
- •Documented cognitive disorder
- •History of major weight loss of 10lbs or more, not due to illness, over the past year
- •Eating disorder (e.g. anorexia, bulimia)
- •Current use of medications known to alter appetite, body weight or brain response including: Anti-epileptics; Glucocorticoids; Antipsychotics; Stimulants for ADHD
- •MRI contraindication (e.g. implanted metal, claustrophobia, inability to fit in MRI scanner)
- •Weight >330 pounds (MRI limit)
- •Severe food allergies, vegetarian, or vegan, or unable to eat study foods
- •Currently in formal weight loss program
结局指标
主要结局
Hypothalamic gliosis
时间窗: 2 years
Evidence of hypothalamic gliosis as measured by T2 relaxation time using MRI
Habitual dietary intake
时间窗: 2 years
Dietary intake in children by 24-hour dietary recalls
Obesity
时间窗: 2 years
Child BMI z-score calculated by the measures of height and weight
次要结局
未报告次要终点
研究者
Ellen Schur, MD, MS
Associate Professor, School of Medicine
University of Washington