Neural Response to Eating and Weight Status (NEWS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01228097
First received: October 22, 2010
Last updated: May 20, 2014
Last verified: December 2011
  Purpose

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).


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Neural Response to Eating After Bariatric Surgery: MRI Results

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood will be drawn for safety labs. Blood plasma will be archived for analysis.


Estimated Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastric Bypass
Participants who receive gastric bypass surgery.
Principally Restrictive Surgery
Participants who receive gastric banding or sleeve gastrectomy surgery.
Weight Stable
Participants who remain weight stable.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228097

Locations
United States, Pennsylvania
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Thomas A. Wadden, PhD University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01228097     History of Changes
Other Study ID Numbers: R01-DK085615
Study First Received: October 22, 2010
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014