Cognitive Effects of Bariatric Surgery
2 other identifiers
observational
253
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 1, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 7, 2018
March 1, 2018
4.5 years
May 1, 2008
March 5, 2018
Conditions
Keywords
Study Arms (2)
Bariatric surgery patients
Weight loss programs
Eligibility Criteria
Participants will be recruited from the bariatric and weight loss programs of affiliated clinical centers.
You may qualify if:
- years of age
- Enrolled in LABS project
- English-speaking
You may not qualify if:
- History of neurological disorder or injury (e.g. dementia, stroke, seizures)
- Moderate or severe head injury (defined as \>10 minutes loss of consciousness; Alexander, 1995)
- Past or current history of severe psychiatric illness (e.g. schizophrenia, bipolar disorder)
- Past or current history of alcohol or drug abuse (defined by DSM-IV criteria)
- History of learning disorder or developmental disability (defined by DSM-IV criteria)
- Impaired sensory function
- No history of bariatric surgery procedures
- No interest in bariatric surgery procedures in the next two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia
New York, New York, 10065, United States
Related Publications (1)
Garcia S, Fedor A, Spitznagel MB, Strain G, Devlin MJ, Cohen RA, Paul RH, Crosby RD, Mitchell JE, Gunstad J. Patient reports of cognitive problems are not associated with neuropsychological test performance in bariatric surgery candidates. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):797-801. doi: 10.1016/j.soard.2012.10.008. Epub 2012 Oct 30.
PMID: 23245496DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Gunstad, Ph.D.
Kent State University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2008
First Posted
May 5, 2008
Study Start
September 1, 2005
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
March 7, 2018
Record last verified: 2018-03