Clinical Trials Logo

Clinical 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. 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03582748
Study type Observational
Source Hartford Hospital
Contact Pavlos K Papasavas, MD
Phone 8604901416
Email Pavlos.Papasavas@hhchealth.org
Status Recruiting
Phase
Start date January 25, 2019
Completion date September 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2