Cognitive Effects of Bariatric Surgery

NCT ID: NCT00671775

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 253 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2010-03-31

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.

Conditions

Bariatric Surgery Patients

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Bariatric surgery patients

No interventions assigned to this group

Weight loss programs

No interventions assigned to this group

Eligibility Criteria

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

• No history of bariatric surgery procedures
• No interest in bariatric surgery procedures in the next two years

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Kent State University

OTHER

Sponsor Role: collaborator

Neuropsychiatric Research Institute, Fargo, North Dakota

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Gunstad, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kent State University

Locations

Columbia

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23245496 (View on PubMed)

Other Identifiers

R01DK075119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK75119

Identifier Type: -

Identifier Source: org_study_id