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

New York Obesity and Nutrition Research Center

Status: Completed

Conditions: Obesity

Treatments: Procedure: Fed Condition; Procedure: Fasted Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT01590914

08-174

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Roux-En Y Gastric Bypass

Experimental group

Description:

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.

Treatment:

Procedure: Fasted Condition

Procedure: Fed Condition

Gastric Banding

Experimental group

Description:

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.

Treatment:

Procedure: Fasted Condition

Procedure: Fed Condition

Formula Diet Weight-Loss

Experimental group

Description:

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.

Treatment:

Procedure: Fasted Condition

Procedure: Fed Condition

No Treatment

Experimental group

Description:

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.

Treatment:

Procedure: Fasted Condition

Procedure: Fed Condition