Clinical trial NCT01583725: fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery
Official title: Functional Brain Imaging and Appetite-Related Hormones Pre and Post Obesity Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Weight loss
fMRI
gut peptides
Lead sponsor: New York Obesity and Nutrition Research Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: St. Luke's-Roosevelt Hospital Center
First posted: 2012-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery.

Obese persons between the ages of 18 \& 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.

Detailed description: Currently, the only effective long term treatment for severe obesity is bariatric surgery.2 Nearly 200,000 procedures are performed each year, with this number increasing rapidly.3 However, the mechanisms of reduced food intake and weight loss after obesity surgery, particularly Rouen-Y gastric bypass (RYGB), are not well understood. This study utilizes functional magnetic resonance imaging (fMRI) and measures of appetite-related gut peptide levels pre and post bariatric surgery to investigate the neurological and hormonal mechanisms involved in initiation and termination of meals.

The general objective is to better understand the physiological changes resulting in weight loss from obesity surgery, particularly Roux-en-Y gastric bypass (RYGB). The main hypothesis is that the differential mechanisms of action in RYGB will alter the signals involved in the initiation and termination of meals, reflected by changes in both peptide hormone levels and regional brain activity in response to foods. The investigators anticipate that the trigger for meal initiation by potent food stimuli will be diminished following RYGB, as indicated by reduced brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). RYGB will be compared to: a. Gastric Banding (GB), representing the restrictive component of surgery, which itself enhances fullness, but in the absence of any rerouting of the gut, should result in fewer changes in gut peptide levels and brain activation; b. Weight Loss (WL) on a formula diet over 3 mo, which represents the weight loss component of surgery; and c. No Treatment (NT), a general control, with no gastric restriction or weight loss. These group comparisons will help parse the contributions of RYGB surgery to weight loss.

The plan is to study clinically severe obese subjects (S's) pre surgery, and at 3 and 18 mo post surgery. The investigators will examine: 1) fMRI brain activation in response to food stimuli and 2) appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. The findings should reveal potential mechanisms associated with the changes in appetite, eating behaviors, and body weight, both during the rapid weight loss phase at 3 mo post surgery as well as when weight typically stabilizes at a nadir at 18 mo post surgery. The investigators plan to enroll 160 patients: 40 with RYGB, 40 GB, 40 WL, and 40 NT (4-arm study). S's will be within the BMI range of 40-50 and matched across groups for BMI, gender (3:1, f:m), and BED status.

Eligibility criteria: Inclusion Criteria:

* BMI range 35-50 kg/m\^2

Exclusion Criteria:

* diabetes,
* smoking,
* pregnancy

Primary outcomes:
measure: Change in brain activation in response to visual and auditory food cues
timeFrame: 3 mo pre-surgery and 3 and 18 mo post-surgery
Secondary outcomes:
measure: Anthropometrics and Body Composition
timeFrame: 3 mo pre-surgery and 3 and 18 mo post-surgery
measure: Mood Measures
timeFrame: 3 mo pre-surgery and 3 and 18 mo post-surgery
measure: Change in appetite-related gut peptide levels
timeFrame: 3 mo pre-surgery and 3 and 18 mo post-surgery
measure: Eating Behavior
timeFrame: 3 mo pre-surgery and 3 and 18 mo post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital, Columbia University
name: Allan Geliebter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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