Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery

• Conditions: Obesity, Morbid; Bariatric Surgery Candidate
• Interventions: Behavioral: Surgery

• Registration Number: NCT05215886
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 9500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	Patients scheduled for or have already completed Weight Loss Surgery at UC Davis Medical Center

Primary Outcome Measures

Name	Time	Method
California Verbal Learning Test-3rd Edition (CVLT-3)	12 Months after index screening/date of surgery	Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory

Secondary Outcome Measures

Name	Time	Method
WAIS-IV Digit Span Forward & Backward	12 months after Index screening/date of surgery	Measures auditory Attention (Forward), and Auditory attention and working memory (Backward)
Stroop Color and Word Test; Word, Color & Word-Color	12 months after index screening/date of surgery	Measures reading speed (word), naming speed (processing) and selective attention and inhibition (attention/executive functioning)
Brief Visuospatial Memory Test	Pre-operatively	Measures visuospatial learning and memory, including visual learning, immediate memory, and delayed memory.
Trial Making Test, A & B	12 months after index screening/date of surgery	Measures visual spatial attention, motor speed and cognitive flexibility
Verbal Fluency, Phonemic & Semantic	12 months after index screening/date of surgery	Measures verbal fluency by a word generation task based on letter \& category (executive functioning)

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States