Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05215886
• Other study ID #: 1812245
• Status: Enrolling by invitation
• Start date: January 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cognitive Dysfunction
• Obesity
• Obesity, Morbid

Intervention

Behavioral:
• Surgery
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

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	California Verbal Learning Test-3rd Edition (CVLT-3)	Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory	Pre-operatively
Primary	California Verbal Learning Test-3rd Edition (CVLT-3)	Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory	12 Months after index screening/date of surgery
Secondary	Brief Visuospatial Memory Test	Measures visuospatial learning and memory, including visual learning, immediate memory, and delayed memory.	Pre-operatively and 12 months after index screening/date of surgery
Secondary	Brief Visuospatial Memory Test	Measures visuospatial learning and memory, including visual learning, immediate memory, and delayed memory.	Pre-operatively
Secondary	Trial Making Test, A & B	Measures visual spatial attention, motor speed and cognitive flexibility	12 months after index screening/date of surgery
Secondary	WAIS-IV Digit Span Forward & Backward	Measures auditory Attention (Forward), and Auditory attention and working memory (Backward)	Pre-Operatively
Secondary	WAIS-IV Digit Span Forward & Backward	Measures auditory Attention (Forward), and Auditory attention and working memory (Backward)	12 months after Index screening/date of surgery
Secondary	Verbal Fluency, Phonemic & Semantic	Measures verbal fluency by a word generation task based on letter & category (executive functioning)	Pre-operatively
Secondary	Verbal Fluency, Phonemic & Semantic	Measures verbal fluency by a word generation task based on letter & category (executive functioning)	12 months after index screening/date of surgery
Secondary	Stroop Color and Word Test; Word, Color & Word-Color	Measures reading speed (word), naming speed (processing) and selective attention and inhibition (attention/executive functioning)	Pre-Operatively
Secondary	Stroop Color and Word Test; Word, Color & Word-Color	Measures reading speed (word), naming speed (processing) and selective attention and inhibition (attention/executive functioning)	12 months after index screening/date of surgery