NCT05215886

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jan 2022Dec 2028

Study Start

First participant enrolled

January 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

January 18, 2022

Last Update Submit

December 3, 2025

Conditions

Obesity, MorbidBariatric Surgery Candidate

Keywords

ObesityBariatric SurgeryCognitive Screening

Outcome Measures

Primary Outcomes (2)

  • California Verbal Learning Test-3rd Edition (CVLT-3)

    Measures episodic verbal learning including Verbal Learning, immediate memory, and delayed memory

    Pre-operatively

  • 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 Outcomes (9)

  • Brief Visuospatial Memory Test

    Pre-operatively and 12 months after index screening/date of surgery

  • Brief Visuospatial Memory Test

    Pre-operatively

  • Trial Making Test, A & B

    12 months after index screening/date of surgery

  • WAIS-IV Digit Span Forward & Backward

    Pre-Operatively

  • WAIS-IV Digit Span Forward & Backward

    12 months after Index screening/date of surgery

  • +4 more secondary outcomes

Study Arms (1)

Surgery

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

Behavioral: Surgery

Interventions

SurgeryBEHAVIORAL

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

Surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related 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.

    PMID: 23625587RESULT

  • 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.

    PMID: 31794778RESULT

  • 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.

    PMID: 24727365RESULT

  • 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.

    PMID: 22771689RESULT

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Victoria Lyo, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

December 5, 2025

Record last verified: 2025-12

Locations

US(1)