An observational study in Obesity, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-10.
Sponsored by University of Pennsylvania · Observational
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).
We hypothesize that RYGB-treated patients will exhibit greater reductions (from baseline) in BOLD response in areas associated with homeostatic and hedonic eating than will both LAGB/LSG and control patients. We also expect that LAGB/LSG patients (as a result of hormonal changes occurring with weight loss) will display greater increases in BOLD response to images of highly palatable foods than will extremely obese controls.
We expect that RYGB-treated patients will show larger increases (relative to baseline) in postprandial GLP-1 and PYY3-36 than the LAGB/LSG and obese control groups. We will also compare changes in ghrelin in the three groups. We predict that patients who undergo RYGB will have greater reductions in ghrelin than will control subjects.
We expect that RYGB-treated patients will demonstrate greater postprandial changes (relative to baseline) in brain activity in the homeostatic and hedonic feeding areas (suggesting normalization of satiety and of neural processing of food reward) than will patients who undergo LAGB/LSG or who do not seek weight loss.
University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with extreme obesity (i.e., BMI 40 kg/m2) or moderate obesity (BMI 35.0-39.9 kg/m2) plus significant weight-related comorbidities.
Exclusion Criteria:
Participants who receive gastric bypass surgery.
Participants who receive gastric banding or sleeve gastrectomy surgery.
Participants who remain weight stable.
To compare changes in BOLD response to images of high-calorie foods in RYGB patients, LAGB/LSG patients, and untreated controls.
Time frame: Baseline, 6-Months, 18-Months
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania