Neural Response to Eating and Weight Status

NCT01228097 | Completed DMC

• 1 other identifier: R01DK085615
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 31290107 DERIVED

• 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.

  PMID: 28004304 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas A. Wadden, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 10, 2015

Record last verified: 2011-12

Locations

US (1)