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Cognitive Effects of Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT00671775
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Columbia University
Weill Medical College of Cornell University
Kent State University
Neuropsychiatric Research Institute, Fargo, North Dakota
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.


Condition or disease
Bariatric Surgery Patients

Study Type : Observational
Actual Enrollment : 253 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cognitive Effects of Bariatric Surgery
Actual Study Start Date : September 2005
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Bariatric surgery patients
Weight loss programs




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from the bariatric and weight loss programs of affiliated clinical centers.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671775


Locations
United States, New York
Columbia
New York, New York, United States, 10065
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
Investigators
Principal Investigator: John Gunstad, Ph.D. Kent State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00671775     History of Changes
Other Study ID Numbers: DK75119
R01DK075119 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Bariatric Surgery
Obesity
Cognitive Function