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ObesityNCT03582748

Neuroimaging Predictors of Bariatric Surgical Outcome

An observational study of Obesity, run by Hartford Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

United States1 site
  • Hartford Hospital

    Hartford, Connecticut, 06102

Other trials in United States

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 groups in NCT03582748
Study groupRoleWhat they receive
New surgical subjectsThis 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 subjectsThis 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 subjectsThis 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.

  1. Body weight

    Measured: up to 7 years

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted11 Jul 2018
  2. Study start25 Jan 2019
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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)
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

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.

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