ObesityNCT03582748
Neuroimaging Predictors of Bariatric Surgical Outcome
An observational study of Obesity, run by Hartford Hospital at 1 site in United States.
Trial summary
Bariatric surgery is an important treatment option for morbidly obese patients who fail to lose weight through diet and exercise. Despite intervention, 20-50% of patients either fail to lose targeted amounts of weight or regain weight that was lost initially. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- sleeve gastrectomy and No sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 1 Sep 2024
- Phase
- Observational
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Bariatric surgery patients who have elected to receive sleeve gastrectomy (SG) surgery or who were pursuing SG but were not candidates for surgery.
Who may be able to join
- Right handed
- Scheduled to undergo sleeve gastrectomy at the Hartford Hospital Surgical Weight Loss center (new surgical subjects)
- able to understand purpose of study as presented in English
Who cannot join
- Auditory or visual impairment that interferes with test-taking.
- Mental retardation (WAIS Full Scale IQ<70).
- Traumatic brain injury with loss of consciousness > 10 minutes or concussion in last 20 days.
- Presence or history of any medical/neurologic illness that may affect brain physiology (e.g., epilepsy, multiple sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a licensed radiologist).
- Current pregnancy (all pre-menopausal females (i.e., those still having menstrual periods) will be tested with urine screens on the day of MRI).
- Presence of marijuana, cocaine, opiates, alcohol or substance dependence. All participants will receive a urine screen for the presence of marijuana, cocaine, opiates and a breath screen to detect the presence of alcohol. Any positive substance screen will result in exclusion. Subjects with substance dependence will be excluded, including those dependent on caffeine and nicotine based on psychiatric interviews and instruments such as the Fagerstrom Test of Nicotine Dependence
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- Any tobacco use.
- Current or lifetime SCID Axis I DSM-IV-TR psychotic disorder diagnosis, substance abuse/dependence diagnosis or report of psychotic disorder in a first-degree relative.
- Inability to understand spoken English sufficiently to comprehend testing procedures available in English, inability to speak English fluently (or is non-native English speaker or was educated in a primary language other than English past grade 1).
- Inability to comprehend the consent form appropriately.
- Other specific fMRI exclusions, including metal devices, clips or fragments in body.
- Body weight > 550 lb (due to the weight restrictions of the MRI table).
- Left handedness.
Trial locations and contacts
1 site in 1 country.
About this study
Bariatric surgery is an important treatment option for morbidly obese patients who fail to lose weight through diet and exercise. Despite intervention, 20-50% of patients either fail to lose targeted amounts of weight or regain weight that was lost initially. Attempts at predicting degree of weight loss have had only modest success and none have long term (>2 year) reliability. Moreover, research predicting weight loss beyond the 1st or 2nd year post-surgery and for outcomes other than weight loss including comorbidities common in the bariatric population is lacking. The investigators' pilot data in 45 patients suggest that individual differences on pre-surgical neural activity measured with functional MRI (fMRI) reliably explains 33% of the variance in weight loss up to 1 year post surgery, and over 50% of a multifaceted outcome measure, far outperforming many other indicators. These predictors implicate regions that closely conform to a theoretical model emphasizing both consummatory urges (a "Now" neural circuit) vs. regulation of craving and self-control (a "Later" circuit). The central hypothesis in this study is that individual differences in these neural pathways exert a powerful effect on the ability to sustain weight loss and achieve other key health outcomes.
The study will replicate and refine this model over a longer timeframe and assess its predictive utility for key weight-related health outcomes. The investigators propose to replicate the model derived from their fMRI pilot data and secondarily to explore its predictive utility for changes in calorie intake, activity levels, liver fat, hemoglobin A1c, plasma lipids, blood pressure, and fasting glucose in a new, independent cohort of N=150 successively consenting, presurgical sleeve gastrectomy (SG) patients in study years 1-3. The study will follow the pilot cohort for up to 7 years and the new cohort for 3 or more years to determine if predictors replicated in Aim 1 retain their long-term predictive power, particularly when supplemented with non-brain imaging variables and using a larger longitudinal dataset. The study will use imaging and non-imaging data to develop multivariate statistical models incorporating energy balance, fMRI, and laboratory values with the variables described in Aim 1 to help to separate predictors vs. consequences of post-surgical outcomes. To help separate scan-to-scan variability from true post-surgical, trajectory-related brain changes, the study will enroll N=20 obese subjects who will not undergo bariatric surgery, and are individually matched with the above SG subjects. Finally, the study will evaluate whether several related, non-fMRI cognitive tests might potentially act as surrogates in clinical practice.
- Conditions
- Obesity
- Being tested
- sleeve gastrectomy, No sleeve gastrectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomyProcedure or surgery
removal of most of stomach as a bariatric surgical procedure
No sleeve gastrectomyProcedure or surgery
Non-receipt of sleeve gastrectomy procedure
| Study group | Role | What they receive |
|---|---|---|
| New surgical subjects | This group will be consist of 150 consecutively consented subjects who are scheduled to have sleeve gastrectomy at the Hartford Hospital Surgical Weight Loss Center. Receives: Procedure: sleeve gastrectomy | |
| Carry over surgical subjects | This group will include 45 subjects who participated in the pilot study and who will be contacted and consented into the present study. Receives: Procedure: sleeve gastrectomy | |
| Non-surgical subjects | This group will include 15 non-surgical patients who will be group-matched to Group A on pertinent characteristics. These patients will be non-surgical in that they will have been evaluated for bariatric surgery by the SWLC but deemed ineligible for any of a number of reasons. Receives: Procedure: No sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: up to 7 years
Secondary outcomes (3)
Regulation of Craving (ROC) functional MRI (fMRI) Task
This task tests food cue- induced craving and the ability to regulate craving. Participants are given an instruction, see pictures of high-calorie foods (previously shown to increase craving) and then rate their craving on a scale from 1 (not at all) to 5 (a lot).
Measured: up to 7 years
Monetary Incentive Delay Task (MID) fMRI Task
Participants see cues that they may win or lose money ($0, $1, $5), then wait for a variable anticipatory delay period, and respond to a rapidly presented target with a single button press to try to either win or avoid losing money.
Measured: up to 7 years
Affective Pictures Paradigm (APP) fMRI Task
This task examines neural activity elicited by incidental emotional processing that engages emotional systems. Forty-two single-face pictures (14 happy, 14 angry and 14 neutral expressions) are presented in pseudorandom order for 3 sec with a 9-sec inter-stimulus interval during which a fixation cross serves as a baseline measure. Participants are instructed to identify via button press whether the face was male or female.
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start25 Jan 2019
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582748
- Sponsor's protocol ID
- HHC-2017-0147
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2018
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Predictors of Bariatric Surgical Outcome
- ClinicalTrials.gov ID
- NCT03582748
- Acronym / sponsor ID
- HHC-2017-0147
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 11 Jul 2018 (actual)
- 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.
Bariatric surgery is an important treatment option for morbidly obese patients who fail to lose weight through diet and exercise. Despite intervention, 20-50% of patients either fail to lose targeted amounts of weight or regain weight that was lost initially. Attempts at predicting degree of weight loss have had only modest success and none have long term (>2 year) reliability. Moreover, research predicting weight loss beyond the 1st or 2nd year post-surgery and for outcomes other than weight loss including comorbidities common in the bariatric population is lacking. The investigators' pilot data in 45 patients suggest that individual differences on pre-surgical neural activity measured with functional MRI (fMRI) reliably explains 33% of the variance in weight loss up to 1 year post surgery, and over 50% of a multifaceted outcome measure, far outperforming many other indicators. These predictors implicate regions that closely conform to a theoretical model emphasizing both consummatory urges (a "Now" neural circuit) vs. regulation of craving and self-control (a "Later" circuit). The central hypothesis in this study is that individual differences in these neural pathways exert a powerful effect on the ability to sustain weight loss and achieve other key health outcomes.
The study will replicate and refine this model over a longer timeframe and assess its predictive utility for key weight-related health outcomes. The investigators propose to replicate the model derived from their fMRI pilot data and secondarily to explore its predictive utility for changes in calorie intake, activity levels, liver fat, hemoglobin A1c, plasma lipids, blood pressure, and fasting glucose in a new, independent cohort of N=150 successively consenting, presurgical sleeve gastrectomy (SG) patients in study years 1-3. The study will follow the pilot cohort for up to 7 years and the new cohort for 3 or more years to determine if predictors replicated in Aim 1 retain their long-term predictive power, particularly when supplemented with non-brain imaging variables and using a larger longitudinal dataset. The study will use imaging and non-imaging data to develop multivariate statistical models incorporating energy balance, fMRI, and laboratory values with the variables described in Aim 1 to help to separate predictors vs. consequences of post-surgical outcomes. To help separate scan-to-scan variability from true post-surgical, trajectory-related brain changes, the study will enroll N=20 obese subjects who will not undergo bariatric surgery, and are individually matched with the above SG subjects. Finally, the study will evaluate whether several related, non-fMRI cognitive tests might potentially act as surrogates in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New surgical subjects | – | Procedure: sleeve gastrectomyThis group will be consist of 150 consecutively consented subjects who are scheduled to have sleeve gastrectomy at the Hartford Hospital Surgical Weight Loss Center. |
| Carry over surgical subjects | – | Procedure: sleeve gastrectomyThis group will include 45 subjects who participated in the pilot study and who will be contacted and consented into the present study. |
| Non-surgical subjects | – | Procedure: No sleeve gastrectomyThis group will include 15 non-surgical patients who will be group-matched to Group A on pertinent characteristics. These patients will be non-surgical in that they will have been evaluated for bariatric surgery by the SWLC but deemed ineligible for any of a number of reasons. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Bariatric surgery patients who have elected to receive sleeve gastrectomy (SG) surgery or who were pursuing SG but were not candidates for surgery.
Key inclusion criteria (3 listed)
- Right handed
- Scheduled to undergo sleeve gastrectomy at the Hartford Hospital Surgical Weight Loss center (new surgical subjects)
- able to understand purpose of study as presented in English
Key exclusion criteria (13 listed)
- Auditory or visual impairment that interferes with test-taking.
- Mental retardation (WAIS Full Scale IQ<70).
- Traumatic brain injury with loss of consciousness > 10 minutes or concussion in last 20 days.
- Presence or history of any medical/neurologic illness that may affect brain physiology (e.g., epilepsy, multiple sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a licensed radiologist).
- Current pregnancy (all pre-menopausal females (i.e., those still having menstrual periods) will be tested with urine screens on the day of MRI).
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 |
|---|---|---|
| sleeve gastrectomyremoval of most of stomach as a bariatric surgical procedure | Procedure or surgery | Carry over surgical subjects, New surgical subjects |
| No sleeve gastrectomyNon-receipt of sleeve gastrectomy procedure | Procedure or surgery | Non-surgical subjects |
Primary outcome
Body weight
Time frame: up to 7 years
3 secondary outcomes
Regulation of Craving (ROC) functional MRI (fMRI) Task
Time frame: up to 7 years
Monetary Incentive Delay Task (MID) fMRI Task
Time frame: up to 7 years
Affective Pictures Paradigm (APP) fMRI Task
Time frame: up to 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hartford Hospital at 1 site 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Body weight (time frame: up to 7 years). 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 11 Jun 2024.