ObesityNCT01590914
Brain Activation in Response to Appetitive Cues Pre- and Post- Bariatric Surgery
A study testing Fed Condition and Fasted Condition in people with Obesity, run by New York Obesity and Nutrition Research Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fed Condition and Fasted Condition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 and < 65 years
- BMI > 40 and < 50kg/m2
- Right handed
- Good comprehension of English
Who cannot join
- > 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St Luke's Roosevelt Hospital Center
New York, New York, 10025
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery
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.
- Conditions
- Obesity
- Being tested
- Fed Condition, Fasted Condition
- Keywords
- Roux-en-Y Bariatric surgery,, Gastric banding,, fMRI,, food cues
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fed ConditionProcedure or surgery
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.
Fasted ConditionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fed Condition; Procedure: 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. Receives: Procedure: Fed Condition; Procedure: 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. Receives: Procedure: Fed Condition; Procedure: 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. Receives: Procedure: Fed Condition; Procedure: Fasted Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-surgery, 1mo post and 3mo post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Obesity and Nutrition Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center, Columbia University
- Responsible party
- Principal investigator, Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
- Investigators
- Allan Geliebter, PhD, Principal investigator, New York Nutrition & Obesity Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590914
- Sponsor's protocol ID
- 08-174
- Status last verified
- Aug 2024
- First submitted
- 1 May 2012
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01590914
- Acronym / sponsor ID
- 08-174
- Conditions
- Obesity
- Keywords
- Roux-en-Y Bariatric surgery,, Gastric banding,, fMRI,, food cues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- New York Obesity and Nutrition Research CenterUniversity, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center, Columbia University
- Study start
- Jan 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Roux-En Y Gastric Bypass | Experimental | Procedure: Fed Condition, Procedure: Fasted Condition40 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. |
| Gastric Banding | Experimental | Procedure: Fed Condition, Procedure: Fasted Condition40 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. |
| Formula Diet Weight-Loss | Experimental | Procedure: Fed Condition, Procedure: Fasted Condition40 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. |
| No Treatment | Experimental | Procedure: Fed Condition, Procedure: Fasted Condition40 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 and < 65 years
- BMI > 40 and < 50kg/m2
- Right handed
- Good comprehension of English
Key exclusion criteria (6 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fed ConditionSubjects 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. | Procedure or surgery | Formula Diet Weight-Loss, Gastric Banding, No Treatment, Roux-En Y Gastric Bypass |
| Fasted ConditionSubjects 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 | Procedure or surgery | Formula Diet Weight-Loss, Gastric Banding, No Treatment, Roux-En Y Gastric Bypass |
Primary outcome
BOLD signal response to visual and auditory food cues
Time frame: pre-surgery, 1mo post and 3mo post surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Geliebter, PhD principal investigator
New York Nutrition & Obesity Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fed Condition and Fasted Condition in people with Obesity, run by New York Obesity and Nutrition Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal response to visual and auditory food cues (time frame: pre-surgery, 1mo post and 3mo post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.