NCT01590914

Brief Summary

Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain activation in response to highly palatable (high energy density \[kcal/g\]), less palatable and non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing bariatric surgery (in surgery patients) and at equivalent times for control groups in fed and fasted conditions at each time point. Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month formula weight loss program or (ii) those who qualify, but do not undergo bariatric surgery, and receive no weight loss treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

6 years

First QC Date

May 1, 2012

Last Update Submit

August 23, 2024

Conditions

Obesity

Keywords

Roux-en-Y Bariatric surgery,Gastric banding,fMRI,food cues

Outcome Measures

Primary Outcomes (1)

  • BOLD signal response to visual and auditory food cues

    BOLD signal changes in the brain in response to highly palatable (high energy density \[kcal/g\]), less palatable (low energy density)and non-food, stimuli in severely obese women pre-surgery, 1 month post-surgery and 3 months post bariatric surgery

    pre-surgery, 1mo post and 3mo post surgery

Study Arms (4)

Roux-En Y Gastric Bypass

EXPERIMENTAL

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.

Procedure: Fed ConditionProcedure: Fasted Condition

Gastric Banding

EXPERIMENTAL

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.

Procedure: Fed ConditionProcedure: Fasted Condition

Formula Diet Weight-Loss

EXPERIMENTAL

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.

Procedure: Fed ConditionProcedure: Fasted Condition

No Treatment

EXPERIMENTAL

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.

Procedure: Fed ConditionProcedure: Fasted Condition

Interventions

Fed ConditionPROCEDURE

Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.

Formula Diet Weight-LossGastric BandingNo TreatmentRoux-En Y Gastric Bypass
Fasted ConditionPROCEDURE

Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues

Formula Diet Weight-LossGastric BandingNo TreatmentRoux-En Y Gastric Bypass

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 and \< 65 years
  • BMI \> 40 and \< 50kg/m2
  • Right handed
  • Good comprehension of English

You may not qualify if:

  • \> 5% weight fluctuation in the past 3 months
  • Presence of disease (including diabetes)
  • Pregnancy, lactation or planning to become pregnant in next 18mon
  • Smoking, or or recent (within past 12 month) smoking cessation
  • Consumption of \> 3 alcoholic beverages per day
  • Left handed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Luke's Roosevelt Hospital Center

New York, New York, 10025, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allan Geliebter, PhD

    New York Nutrition & Obesity Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 3, 2012

Study Start

January 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

US(2)