Cognitive Effects of Bariatric Surgery

Bariatric Surgery Patients Clinical Trial

Official title:

Cognitive Effects of Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671775
• Other study ID #: DK75119
• Secondary ID: R01DK075119
• Status: Completed
• Phase: N/A
• First received: May 1, 2008
• Last updated: March 5, 2018
• Start date: September 2005
• Est. completion date: March 2010

Study information

• Verified date: March 2018
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Patients

Locations

Country	Name	City	State
United States	Columbia	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Columbia University, Kent State University, Neuropsychiatric Research Institute, Fargo, North Dakota, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States,