Clinical trial NCT05215886: Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery
Official title: Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Keywords: Obesity
Bariatric Surgery
Cognitive Screening
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 9500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects seeking weight loss surgery or with a history of weight loss surgery at University of California Davis Medical Center 18 years of age or older

Brief summary: Study is designed to screen psychological cognitive baseline and retention/improvement after weight loss surgery.

Detailed description: Patients with morbid obesity have shown to be at increased risk for memory loss and cognitive decline. Obesity and high-fat diets have been associated with deficits in learning, memory, and executive functioning. Bariatric surgery results in significant weight loss for patients and helps resolve obesity-related comorbidities such as diabetes and high blood pressure. Interestingly, bariatric surgery has shown promise in improving some aspects of cognitive function and improved memory. (3-1) Obesity affects brain structure, more specifically the grey and white matter, likely in part by reducing oxygen flow to the various regions in the brain. Studies have shown a correlation between BMI and cerebral blood flow velocity (CBFV), where higher BMI is associated with lower CBFV. Although it is not clear how exactly obesity plays a role in the brain's structural and functional changes, observations revealed compromised grey and white matter integrity, its fiber connectivity or cortical atrophy and metabolic alterations. (2)

Few studies exist on the impact of bariatric surgery on cognition. Some studies have shown that patients with obesity who underwent bariatric surgery had memory and cognitive improvement compared to those who had not undergone surgery. (4) Thus, the investigators hope to add to our understanding of how bariatric surgery can improve cognitive decline and to potentially offer surgery to more patients with baseline cognitive impairment and to improve cognitive function overall for patients with obesity. More longitudinal studies need to be done to connect bariatric surgery effects with cognitive decline, specifically memory.

Eligibility criteria: Inclusion Criteria:

* Cognitive impairment/decline, memory impairment/loss, or Alzheimer's disease or dementia and bariatric surgery • Cognitive impairment/decline, memory impairment/loss, or Alzheimer's disease or dementia and obesity, and no bariatric surgery history

Exclusion Criteria:

* Patients without a history of memory impairment/loss, bariatric surgery, or obesity

  * Patients outside of University of California Davis Health System
  * Patients unable to provide consent

Primary outcomes:
measure: California Verbal Learning Test-3rd Edition (CVLT-3)
timeFrame: Pre-operatively
measure: California Verbal Learning Test-3rd Edition (CVLT-3)
timeFrame: 12 Months after index screening/date of surgery
Secondary outcomes:
measure: Brief Visuospatial Memory Test
timeFrame: Pre-operatively and 12 months after index screening/date of surgery
measure: Brief Visuospatial Memory Test
timeFrame: Pre-operatively
measure: Trial Making Test, A & B
timeFrame: 12 months after index screening/date of surgery
measure: WAIS-IV Digit Span Forward & Backward
timeFrame: Pre-Operatively
measure: WAIS-IV Digit Span Forward & Backward
timeFrame: 12 months after Index screening/date of surgery
measure: Verbal Fluency, Phonemic & Semantic
timeFrame: Pre-operatively
measure: Verbal Fluency, Phonemic & Semantic
timeFrame: 12 months after index screening/date of surgery
measure: Stroop Color and Word Test; Word, Color & Word-Color
timeFrame: Pre-Operatively
measure: Stroop Color and Word Test; Word, Color & Word-Color
timeFrame: 12 months after index screening/date of surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Victoria Lyo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alosco ML, Spitznagel MB, Strain G, Devlin M, Cohen R, Paul R, Crosby RD, Mitchell JE, Gunstad J. Improved memory function two years after bariatric surgery. Obesity (Silver Spring). 2014 Jan;22(1):32-8. doi: 10.1002/oby.20494. Epub 2013 Oct 15.
citation: Nota MHC, Vreeken D, Wiesmann M, Aarts EO, Hazebroek EJ, Kiliaan AJ. Obesity affects brain structure and function- rescue by bariatric surgery? Neurosci Biobehav Rev. 2020 Jan;108:646-657. doi: 10.1016/j.neubiorev.2019.11.025. Epub 2019 Nov 30.
citation: Miller AA, Spencer SJ. Obesity and neuroinflammation: a pathway to cognitive impairment. Brain Behav Immun. 2014 Nov;42:10-21. doi: 10.1016/j.bbi.2014.04.001. Epub 2014 Apr 12.
citation: Stanek KM, Gunstad J. Can bariatric surgery reduce risk of Alzheimer's disease? Prog Neuropsychopharmacol Biol Psychiatry. 2013 Dec 2;47:135-9. doi: 10.1016/j.pnpbp.2012.06.021. Epub 2012 Jul 4.