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A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design

INTRODUCTION: Type 2 diabetes (T2D) is a risk factor for dementia. Ischemia due to vascular pathology is hypothesized to be an underlying mechanism for this association. Hyperbaric oxygen therapy (HBOT) is a treatment in which oxygen‐enriched air (up to 100%) is administered to patients in a chamber...

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Autores principales: BenAri, Ori, Efrati, Shai, Sano, Mary, Bendlin, Barbara B., Lin, HungMo, Liu, Xiaoyu, Sela, Inbar, Almog, Ganit, Livny, Abigail, Sandler, Israel, Ben‐Haim, Simona, Sagi, Roy, LeRoith, Derek, Schnaider Beeri, Michal, Ravona‐Springer, Ramit
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7153432/
https://www.ncbi.nlm.nih.gov/pubmed/32296731
http://dx.doi.org/10.1002/trc2.12008
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author BenAri, Ori
Efrati, Shai
Sano, Mary
Bendlin, Barbara B.
Lin, HungMo
Liu, Xiaoyu
Sela, Inbar
Almog, Ganit
Livny, Abigail
Sandler, Israel
Ben‐Haim, Simona
Sagi, Roy
LeRoith, Derek
Schnaider Beeri, Michal
Ravona‐Springer, Ramit
author_facet BenAri, Ori
Efrati, Shai
Sano, Mary
Bendlin, Barbara B.
Lin, HungMo
Liu, Xiaoyu
Sela, Inbar
Almog, Ganit
Livny, Abigail
Sandler, Israel
Ben‐Haim, Simona
Sagi, Roy
LeRoith, Derek
Schnaider Beeri, Michal
Ravona‐Springer, Ramit
author_sort BenAri, Ori
collection PubMed
description INTRODUCTION: Type 2 diabetes (T2D) is a risk factor for dementia. Ischemia due to vascular pathology is hypothesized to be an underlying mechanism for this association. Hyperbaric oxygen therapy (HBOT) is a treatment in which oxygen‐enriched air (up to 100%) is administered to patients in a chamber at a pressure above one atmosphere absolute. HBOT is approved for the treatment of T2D ischemic non‐healing wounds. Evidence from animal studies and small clinical trials suggests that HBOT improves hypoxic/ischemic brain injuries, consequently inducing brain angiogensis, leading to cognitive improvement. METHODS: We present the design of the first double‐blind, placebo‐controlled, clinical trial on brain and cognitive outcomes in elderly (n = 154) with T2D and mild cognitive impairment to compare the effects of HBOT versus sham (normal air with 1.1 ATA pressure in the first and last 5 minutes of the session). Eligible candidates are randomized with equal probability to HBOT and sham. Outcomes are assessed before and after treatment, and at 6‐ and 12‐month follow‐up. The primary cognitive outcome is global cognitive change, indexed by a composite sum of z‐scores of four executive functions and four episodic memory tests. The primary neurobiological outcome is cerebral blood flow (CBF; via arterial spin labeling magnetic resonance imaging [ASL‐MRI]) and cerebral glucose utilization via fluorodeoxyglucose positron emission tomography (FDG‐PET). Secondary outcome measures are specific cognitive domains (executive function and episodic memory) and functional measures (Clinical Dementia Rating sum of boxes, activities of daily living). Efficacy analyses will be performed for the intent‐to‐treat sample. DISCUSSION: Recent studies suggest that HBOT induces neuroplasticity and improves cognition in post‐stroke and traumatic brain injury patients. However, its effect on cognition, cerebral blood flow, and brain glucose utilization in T2D patients at high dementia risk is yet to be determined. If effective, this study may provide strong evidence for the brain and cognitive benefits of HBOT in this population.
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spelling pubmed-71534322020-04-15 A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design BenAri, Ori Efrati, Shai Sano, Mary Bendlin, Barbara B. Lin, HungMo Liu, Xiaoyu Sela, Inbar Almog, Ganit Livny, Abigail Sandler, Israel Ben‐Haim, Simona Sagi, Roy LeRoith, Derek Schnaider Beeri, Michal Ravona‐Springer, Ramit Alzheimers Dement (N Y) Research Articles INTRODUCTION: Type 2 diabetes (T2D) is a risk factor for dementia. Ischemia due to vascular pathology is hypothesized to be an underlying mechanism for this association. Hyperbaric oxygen therapy (HBOT) is a treatment in which oxygen‐enriched air (up to 100%) is administered to patients in a chamber at a pressure above one atmosphere absolute. HBOT is approved for the treatment of T2D ischemic non‐healing wounds. Evidence from animal studies and small clinical trials suggests that HBOT improves hypoxic/ischemic brain injuries, consequently inducing brain angiogensis, leading to cognitive improvement. METHODS: We present the design of the first double‐blind, placebo‐controlled, clinical trial on brain and cognitive outcomes in elderly (n = 154) with T2D and mild cognitive impairment to compare the effects of HBOT versus sham (normal air with 1.1 ATA pressure in the first and last 5 minutes of the session). Eligible candidates are randomized with equal probability to HBOT and sham. Outcomes are assessed before and after treatment, and at 6‐ and 12‐month follow‐up. The primary cognitive outcome is global cognitive change, indexed by a composite sum of z‐scores of four executive functions and four episodic memory tests. The primary neurobiological outcome is cerebral blood flow (CBF; via arterial spin labeling magnetic resonance imaging [ASL‐MRI]) and cerebral glucose utilization via fluorodeoxyglucose positron emission tomography (FDG‐PET). Secondary outcome measures are specific cognitive domains (executive function and episodic memory) and functional measures (Clinical Dementia Rating sum of boxes, activities of daily living). Efficacy analyses will be performed for the intent‐to‐treat sample. DISCUSSION: Recent studies suggest that HBOT induces neuroplasticity and improves cognition in post‐stroke and traumatic brain injury patients. However, its effect on cognition, cerebral blood flow, and brain glucose utilization in T2D patients at high dementia risk is yet to be determined. If effective, this study may provide strong evidence for the brain and cognitive benefits of HBOT in this population. John Wiley and Sons Inc. 2020-04-13 /pmc/articles/PMC7153432/ /pubmed/32296731 http://dx.doi.org/10.1002/trc2.12008 Text en © 2020 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research Articles
BenAri, Ori
Efrati, Shai
Sano, Mary
Bendlin, Barbara B.
Lin, HungMo
Liu, Xiaoyu
Sela, Inbar
Almog, Ganit
Livny, Abigail
Sandler, Israel
Ben‐Haim, Simona
Sagi, Roy
LeRoith, Derek
Schnaider Beeri, Michal
Ravona‐Springer, Ramit
A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design
title A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design
title_full A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design
title_fullStr A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design
title_full_unstemmed A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design
title_short A double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: Study design
title_sort double‐blind placebo‐controlled clinical trial testing the effect of hyperbaric oxygen therapy on brain and cognitive outcomes of mildly cognitively impaired elderly with type 2 diabetes: study design
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7153432/
https://www.ncbi.nlm.nih.gov/pubmed/32296731
http://dx.doi.org/10.1002/trc2.12008
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