NCT01228097|CompletedDMC
Neural Response to Eating and Weight Status
NEWS
Changes in Neural Response to Eating After Bariatric Surgery: MRI Results
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NEWS
Changes in Neural Response to Eating After Bariatric Surgery: MRI Results
Sponsor study identifier
NIH
observational
75
1 country
1
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 22, 2010
Actual (reported)October 25, 2010
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)To compare changes in BOLD response to images of high-calorie foods in RYGB patients, LAGB/LSG patients, and untreated controls.
Baseline, 6-Months, 18-Months
Participants who receive gastric bypass surgery.
Participants who receive gastric banding or sleeve gastrectomy surgery.
Participants who remain weight stable.
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.
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Sarkar S, Anokye-Danso F, Tronieri JS, Millar JS, Alamuddin N, Wadden TA, Ahima RS. Differential Effects of Roux-en-Y Gastric Bypass Surgery and Laparoscopic Sleeve Gastrectomy on Fatty Acid Levels. Obes Surg. 2019 Dec;29(12):3941-3947. doi: 10.1007/s11695-019-04062-5.
Alamuddin N, Vetter ML, Ahima RS, Hesson L, Ritter S, Minnick A, Faulconbridge LF, Allison KC, Sarwer DB, Chittams J, Williams NN, Hayes MR, Loughead JW, Gur R, Wadden TA. Changes in Fasting and Prandial Gut and Adiposity Hormones Following Vertical Sleeve Gastrectomy or Roux-en-Y-Gastric Bypass: an 18-Month Prospective Study. Obes Surg. 2017 Jun;27(6):1563-1572. doi: 10.1007/s11695-016-2505-5.
Whole blood will be drawn for safety labs. Blood plasma will be archived for analysis.
Thomas A. Wadden, PhD
University of Pennsylvania
75 participants (actual enrollment reported by the registry).
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Making Calories Count: Information Format and Food Choice
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
March 10, 2015
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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