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Cognitive Effects of Bariatric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
First received: May 1, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognitive Effects of Bariatric Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671775

Locations
United States, New York
Columbia
New York City, New York, United States
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
  More Information

No publications provided

Responsible Party: John Gunstad/PI, Kent State University
ClinicalTrials.gov Identifier: NCT00671775     History of Changes
Other Study ID Numbers: DK75119, R01DK075119
Study First Received: May 1, 2008
Last Updated: March 15, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013