An observational study in Bariatric Surgery Patients, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
There is growing evidence that obesity is associated with adverse neurocognitive outcome. Recent studies demonstrate that elevated body mass index (BMI) is an independent risk factor for Alzheimer's disease, structural brain abnormalities, and cognitive dysfunction in older adults. Preliminary work from our lab extends these findings and shows structural brain differences and cognitive dysfunction also exist in obese young and middle-aged adults.
Bariatric surgery is increasingly viewed as an effective intervention for morbid obesity, though its effects on cognition are unknown. Post-operative nutritional deficiencies are common and can adversely impact cognitive performance. However, substantial weight loss resolves or improves many medical conditions with reversible cognitive effects, suggesting bariatric surgery may provide cognitive benefits.
No study to date has examined the cognitive effects of bariatric surgery. To do so, the proposed study will prospectively assess cognitive performance in 125 bariatric surgery patients enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS) project and 125 matched controls. Bariatric surgery patients will complete a computerized cognitive test battery at four time points: pre-operatively, 12 weeks post-operatively, 12 months post-operatively, and 24 months post-operatively. Matched control participants will complete the test battery at similar intervals. Demographic, medical, and psychosocial information will be collected to elucidate possible mechanisms of change. We hypothesize that the substantial weight loss following bariatric surgery will be associated with improved cognitive performance.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from the bariatric and weight loss programs of affiliated clinical centers.
Specific criteria for bariatric surgery patients include:
Inclusion Criteria
Exclusion Criteria
Inclusion/exclusion criteria for matched control participants include:
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)