Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Columbia University Weill Medical College of Cornell University Kent State University Neuropsychiatric Research Institute, Fargo, North Dakota |
---|---|
Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00671775 |
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 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.
Condition |
---|
Bariatric Surgery Patients |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Cognitive Effects of Bariatric Surgery |
Estimated Enrollment: | 250 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
1
updating
|
2
updating
|
Ages Eligible for Study: | 25 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Contact: John Gunstad | 330-672-2589 | jgunstad@kent.edu |
United States, New York | |
Columbia | Recruiting |
New York City, New York, United States | |
Contact: Juli Goldfein |
Principal Investigator: | John Gunstad, Ph.D. | Kent State University |
Responsible Party: | Kent State University ( John Gunstad/PI ) |
Study ID Numbers: | DK75119 |
Study First Received: | May 1, 2008 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00671775 History of Changes |
Health Authority: | United States: Federal Government |
Bariatric Surgery Obesity Cognitive Function |
Obesity |