Brain Activation in Response to Appetitive Cues Pre- and Post- Bariatric Surgery
- Conditions
- Obesity
- Interventions
- Procedure: Fed ConditionProcedure: Fasted Condition
- Registration Number
- NCT01590914
- Lead Sponsor
- New York Obesity and Nutrition Research Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age > 18 and < 65 years
- BMI > 40 and < 50kg/m2
- Right handed
- Good comprehension of English
- > 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Roux-En Y Gastric Bypass Fasted Condition 40 subjects who plan to undergo Roux-En-Y Gastric Bypass bariatric surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery. Formula Diet Weight-Loss Fasted Condition 40 subjects will undertake a 12-week liquid formula weight loss plan. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition pre-weight loss and 3 months after a 12-week weight loss plan. Roux-En Y Gastric Bypass Fed Condition 40 subjects who plan to undergo Roux-En-Y Gastric Bypass bariatric surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery. Gastric Banding Fed Condition 40 Subjects who plan to undergo Gastric Banding bariatric Surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery. Gastric Banding Fasted Condition 40 Subjects who plan to undergo Gastric Banding bariatric Surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery. Formula Diet Weight-Loss Fed Condition 40 subjects will undertake a 12-week liquid formula weight loss plan. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition pre-weight loss and 3 months after a 12-week weight loss plan. No Treatment Fed Condition 40 subjects who do not undergo any treatment for weight loss. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition at baseline and after 3 months. No Treatment Fasted Condition 40 subjects who do not undergo any treatment for weight loss. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition at baseline and after 3 months.
- Primary Outcome Measures
Name Time Method BOLD signal response to visual and auditory food cues 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
St Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States