- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05215886
Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California Davis Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surgery
Patients scheduled for or have already completed Weight Loss Surgery at UC Davis Medical Center
|
Study subjects scheduled for or have already completed weight loss surgery and have already completed psychological screening as part of their pre-surgery work up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
California Verbal Learning Test-3rd Edition (CVLT-3)
Time Frame: Pre-operatively
|
Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory
|
Pre-operatively
|
|
California Verbal Learning Test-3rd Edition (CVLT-3)
Time Frame: 12 Months after index screening/date of surgery
|
Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory
|
12 Months after index screening/date of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Visuospatial Memory Test
Time Frame: Pre-operatively and 12 months after index screening/date of surgery
|
Measures visuospatial learning and memory, including visual learning, immediate memory, and delayed memory.
|
Pre-operatively and 12 months after index screening/date of surgery
|
|
Brief Visuospatial Memory Test
Time Frame: Pre-operatively
|
Measures visuospatial learning and memory, including visual learning, immediate memory, and delayed memory.
|
Pre-operatively
|
|
Trial Making Test, A & B
Time Frame: 12 months after index screening/date of surgery
|
Measures visual spatial attention, motor speed and cognitive flexibility
|
12 months after index screening/date of surgery
|
|
WAIS-IV Digit Span Forward & Backward
Time Frame: Pre-Operatively
|
Measures auditory Attention (Forward), and Auditory attention and working memory (Backward)
|
Pre-Operatively
|
|
WAIS-IV Digit Span Forward & Backward
Time Frame: 12 months after Index screening/date of surgery
|
Measures auditory Attention (Forward), and Auditory attention and working memory (Backward)
|
12 months after Index screening/date of surgery
|
|
Verbal Fluency, Phonemic & Semantic
Time Frame: Pre-operatively
|
Measures verbal fluency by a word generation task based on letter & category (executive functioning)
|
Pre-operatively
|
|
Verbal Fluency, Phonemic & Semantic
Time Frame: 12 months after index screening/date of surgery
|
Measures verbal fluency by a word generation task based on letter & category (executive functioning)
|
12 months after index screening/date of surgery
|
|
Stroop Color and Word Test; Word, Color & Word-Color
Time Frame: Pre-Operatively
|
Measures reading speed (word), naming speed (processing) and selective attention and inhibition (attention/executive functioning)
|
Pre-Operatively
|
|
Stroop Color and Word Test; Word, Color & Word-Color
Time Frame: 12 months after index screening/date of surgery
|
Measures reading speed (word), naming speed (processing) and selective attention and inhibition (attention/executive functioning)
|
12 months after index screening/date of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Victoria Lyo, MD, University of California, Davis
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1812245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.