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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center, New York, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fed Condition

Procedure

Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.

Fasted Condition

Procedure

Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues

Primary outcomes

BOLD signal response to visual and auditory food cues

Time frame: 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

Sponsors and collaborators

Lead sponsor

New York Obesity and Nutrition Research Center

Other

Collaborators

Columbia University
St. Luke's-Roosevelt Hospital Center

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: May 3, 2012
Registry last updated: Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed