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Набор по приглашению NCT05215886

Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery

Наблюдательное Obesity, Morbid Bariatric Surgery Candidate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Surgery.
Кому может быть актуально
Состояния в реестре: Obesity, Morbid, Bariatric Surgery Candidate. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • California Verbal Learning Test-3rd Edition (CVLT-3) [Срок оценки: Pre-operatively]
  • California Verbal Learning Test-3rd Edition (CVLT-3) [Срок оценки: 12 Months after index screening/date of surgery]
Вторичные конечные точки (9)
  • Brief Visuospatial Memory Test [Срок оценки: Pre-operatively and 12 months after index screening/date of surgery]
  • Brief Visuospatial Memory Test [Срок оценки: Pre-operatively]
  • Trial Making Test, A & B [Срок оценки: 12 months after index screening/date of surgery]
  • WAIS-IV Digit Span Forward & Backward [Срок оценки: Pre-Operatively]
  • WAIS-IV Digit Span Forward & Backward [Срок оценки: 12 months after Index screening/date of surgery]
  • Verbal Fluency, Phonemic & Semantic [Срок оценки: Pre-operatively]
  • Verbal Fluency, Phonemic & Semantic [Срок оценки: 12 months after index screening/date of surgery]
  • Stroop Color and Word Test; Word, Color & Word-Color [Срок оценки: Pre-Operatively]
  • Stroop Color and Word Test; Word, Color & Word-Color [Срок оценки: 12 months after index screening/date of surgery]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • University of California Davis Medical Center — Sacramento

Публикации

  • 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 23625587
  • 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 31794778
  • 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 24727365
  • 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 22771689

Идентификаторы

NCT: NCT05215886 · 1812245

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗