Neural Response to Eating and Weight Status

Completed

Conditions studied: Obesity

In brief

This study will compare brain and hormone responses to food images (and food) in women who undergo: (1) gastric bypass surgery; (2) principally restrictive surgery (laparoscopic adjustable gastric banding or laparoscopic sleeve gastrectomy); or (3) no weight loss surgery, with the intent of remaining relatively weight stable (within 10-15 lb of your present weight). The investigators will use magnetic resonance imaging (MRI) to see how the brain responds to pictures of food and to consuming a liquid meal replacement. The investigators wish to determine whether the two surgeries have different effects on appetite, as observable in the brain, and whether the possible effects on appetite differ from those in participants who have a similar body weight but remain relatively weight stable. The investigators also will draw blood to determine how "hunger" and "fullness" hormones change after eating and to see if there are any differences among the three groups. The study is being sponsored by the National Institutes of Health (NIH).

Key facts

Study ID

NCT01228097

Run by

University of Pennsylvania

People needed

75

Starts

2010-04-01

Expected to finish

2015-01-01

Last updated by the study team

2015-03-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women
• Over 18 years old
• BMI of 40 kg/ m2 (or 35 kg/m2 in the presence of significant weight-related comorbidities, including established coronary artery disease, established peripheral arterial disease, symptomatic carotid artery disease, sleep apnea, metabolic syndrome, cardiomyopathy, hypertension, and debilitating joint pain).
• Non-surgical group must be willing to remain weight stable and not seek weight loss (i.e., defined as remaining within 5% of baseline weight).

You may not qualify if…

• Weight > 350 pounds the maximum weight that can be accommodated in the scanner); supine abdominal width (with arms folded above) > 60 cm or sagittal diameter > 50 cm (i.e., these are the maximum dimensions that can be accommodated in the scanner)
• Pregnancy or lactation
• Type 1 or type 2 diabetes
• Severe major depression or other psychiatric disorder that significantly interferes with daily living
• Substance use disorder (current or in remission 1 year)
• Current use of nicotine or any illicit drug
• Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
• Use of weight loss medications or other agents known to affect body weight or blood glucose (e.g., glucocorticoids, second-generation antipsychotic medications)
• Lack of capacity to provide informed consent
• Non-surgical participants interested in losing weight in the next 2 years
• Plans to relocate from the area within 2 years
• Principal Investigator discretion

Where it is running

• University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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