Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- BOLD signal response to visual and auditory food cues
研究概览
简要总结
Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain activation in response to highly palatable (high energy density [kcal/g]), less palatable and non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing bariatric surgery (in surgery patients) and at equivalent times for control groups in fed and fasted conditions at each time point.
Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month formula weight loss program or (ii) those who qualify, but do not undergo bariatric surgery, and receive no weight loss treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 and < 65 years
- •BMI > 40 and < 50kg/m2
- •Right handed
- •Good comprehension of English
排除标准
- •> 5% weight fluctuation in the past 3 months
- •Presence of disease (including diabetes)
- •Pregnancy, lactation or planning to become pregnant in next 18mon
- •Smoking, or or recent (within past 12 month) smoking cessation
- •Consumption of > 3 alcoholic beverages per day
- •Left handed
结局指标
主要结局
BOLD signal response to visual and auditory food cues
时间窗: pre-surgery, 1mo post and 3mo post surgery
BOLD signal changes in the brain in response to highly palatable (high energy density \[kcal/g\]), less palatable (low energy density)and non-food, stimuli in severely obese women pre-surgery, 1 month post-surgery and 3 months post bariatric surgery
次要结局
未报告次要终点
研究者
Dr. Allan Geliebter
Principal Investigator
New York Obesity and Nutrition Research Center