Brain Activation in Response to Appetitive Cues Pre- and Post- Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity

• 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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age > 18 and < 65 years
• BMI > 40 and < 50kg/m2
• Right handed
• Good comprehension of English

Exclusion Criteria

• > 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

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

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