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Neuroimaging Predictors of Bariatric Surgical Outcome
NCT03582748 · View on ClinicalTrials.gov ↗
Study 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. 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 predictiv
Conditions Studied
Interventions
- PROCEDURE sleeve gastrectomy
- PROCEDURE No sleeve gastrectomy
Study Locations (1)
Connecticut
- Hartford Hospital — Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2024-09-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03582748
The ClinicalTrials.gov registry entry for NCT03582748 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 112 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which sleeve gastrectomy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03582748 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03582748 about?
NCT03582748 is a clinical study titled "Neuroimaging Predictors of Bariatric Surgical Outcome". 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 ...
What is the current status of trial NCT03582748?
This trial is currently active not recruiting. The enrollment target is 210 participants. The study started on 2019-01-25. Estimated completion is 2024-09-01.
What conditions does trial NCT03582748 study?
This clinical trial studies the following conditions: Obesity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03582748?
The interventions under investigation include: sleeve gastrectomy (PROCEDURE), No sleeve gastrectomy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03582748?
This trial is sponsored by Hartford Hospital, which has 112 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03582748 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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