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NCT03582748 · ClinicalTrials.gov registry record
Neuroimaging Predictors of Bariatric Surgical Outcome
A clinical trial of Obesity, sponsored by Hartford Hospital.
- Active
- Registry status
- 210
- Enrollment target
- 1
- Study location
NCT03582748: Active study of Obesity, sponsored by Hartford Hospital.
NCT03582748 is a study of Obesity that is active but no longer recruiting, run by Hartford Hospital. The registered enrollment target is 210 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03582748, a study of Obesity, is active but no longer recruiting, sponsored by Hartford Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 210 participants
- Enrollment target
- 1
- Study location
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 |
What the registry record for NCT03582748 still lists
NCT03582748 is an observational study that tracks outcomes without assigning an intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (74% lower).
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.
NCT03582748 reports a single indexed study location in Connecticut.
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.
What interventions are being tested in trial NCT03582748?
The interventions under investigation include: sleeve gastrectomy (PROCEDURE), No sleeve gastrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03582748?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03582748's enrollment target sits among peer trials
210 303rd of 1053 higher than 748 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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