← Back to Search

Bariatric Surgery for Obesity

N/A
Waitlist Available
Led By Allan Geliebter, PhD
Research Sponsored by New York Obesity and Nutrition Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 and < 65 years
BMI > 40 and < 50kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-surgery, 1mo post and 3mo post surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine how the brain responds to food before and after weight-loss surgery, and will compare those results to a control group.

Who is the study for?
This trial is for right-handed, English-speaking women aged 18-65 with severe obesity (BMI between 40 and 50), who haven't had significant weight changes recently. It's not for those with certain diseases like diabetes, smokers or recent quitters, heavy drinkers, left-handed individuals, or those pregnant or planning pregnancy within the next year and a half.
What is being tested?
The study uses fMRI scans to observe brain responses to food-related cues in severely obese women before and after bariatric surgery. Participants are either undergoing Roux-en-Y gastric bypass or gastric banding surgeries compared with two control groups: one on a diet program and another without any treatment.
What are the potential side effects?
There are no direct side effects from the interventions being tested since they involve non-invasive brain imaging under different conditions (fed vs fasted). However, general risks associated with fMRI procedures may include discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
My BMI is between 40 and 50.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery, 1mo post and 3mo post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery, 1mo post and 3mo post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BOLD signal response to visual and auditory food cues

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Roux-En Y Gastric BypassExperimental Treatment2 Interventions
40 subjects who plan to undergo Roux-En-Y Gastric Bypass bariatric surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery.
Group II: No TreatmentExperimental Treatment2 Interventions
40 subjects who do not undergo any treatment for weight loss. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition at baseline and after 3 months.
Group III: Gastric BandingExperimental Treatment2 Interventions
40 Subjects who plan to undergo Gastric Banding bariatric Surgery. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition Pre-Surgery and 3 months post Surgery.
Group IV: Formula Diet Weight-LossExperimental Treatment2 Interventions
40 subjects will undertake a 12-week liquid formula weight loss plan. BOLD fMRI responses to food cues will be collected in the Fed Condition and Fasted Condition pre-weight loss and 3 months after a 12-week weight loss plan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fed Condition
2006
Completed Phase 1
~270
Fasted Condition
2008
N/A
~120

Find a Location

Who is running the clinical trial?

New York Obesity and Nutrition Research CenterLead Sponsor
7 Previous Clinical Trials
503 Total Patients Enrolled
5 Trials studying Obesity
399 Patients Enrolled for Obesity
St. Luke's-Roosevelt Hospital CenterOTHER
95 Previous Clinical Trials
18,176 Total Patients Enrolled
13 Trials studying Obesity
1,230 Patients Enrolled for Obesity
Columbia UniversityOTHER
1,483 Previous Clinical Trials
2,629,872 Total Patients Enrolled
43 Trials studying Obesity
5,965 Patients Enrolled for Obesity

Media Library

Fed Condition Clinical Trial Eligibility Overview. Trial Name: NCT01590914 — N/A
Obesity Research Study Groups: Gastric Banding, Formula Diet Weight-Loss, Roux-En Y Gastric Bypass, No Treatment
Obesity Clinical Trial 2023: Fed Condition Highlights & Side Effects. Trial Name: NCT01590914 — N/A
Fed Condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT01590914 — N/A
~7 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top