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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

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.Check my eligibility
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.See study design
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
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I am between 18 and 65 years old.
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BOLD signal response to visual and auditory food cues

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
~150

Find a Location

Who is running the clinical trial?

New York Obesity and Nutrition Research CenterLead Sponsor
7 Previous Clinical Trials
543 Total Patients Enrolled
5 Trials studying Obesity
439 Patients Enrolled for Obesity
St. Luke's-Roosevelt Hospital CenterOTHER
95 Previous Clinical Trials
18,216 Total Patients Enrolled
13 Trials studying Obesity
1,270 Patients Enrolled for Obesity
Columbia UniversityOTHER
1,448 Previous Clinical Trials
2,531,370 Total Patients Enrolled
40 Trials studying Obesity
5,924 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 Jul 2025