This trial is active, not recruiting.

Condition bariatric surgery patients
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator Columbia University
Start date September 2005
End date March 2010
Trial size 250 participants
Trial identifier NCT00671775, DK75119, R01DK075119


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Eligibility Criteria

Male or female participants from 25 years up to 70 years old.

Specific criteria for bariatric surgery patients include: Inclusion Criteria - 25-65 years of age - Enrolled in LABS project - English-speaking Exclusion Criteria - 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 Inclusion/exclusion criteria for matched control participants include: - All of the inclusion/exclusion criteria for the surgical patients, except for enrollment in the LABS project - No history of bariatric surgery procedures - No interest in bariatric surgery procedures in the next two years

Additional Information

Official title Cognitive Effects of Bariatric Surgery
Principal investigator John Gunstad, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).