Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628297
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Comparison of Differencens in VO2-max Perfusion of the Heart and Brain and Cognitive Performance Between Patients with Type 2 Diabetes and Healthy Age Matched Controls
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Small Vessel Disease of the Brain and Heart a PET Perfusion Study of Training Effects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SVAT
Brief Summary:
In the aging population ischemic heart disease stroke and dementia are increasingly prevalent Diagnosis and treatment of the former two ie large-vessel coronary heart disease and endovascular thrombectomy of the brain in relation to stroke have improved significantly Yet the majority of elderly patients with ischemic heart disease do not have large-vessel heart disease and it seems that small vessel disease SVD may explain a large fraction of these cases as well as the cardiovascular morbidity in the elderly Hence the current development in diagnostics and treatments of ischemic heart disease does not address the most common subtype of ischemic disease seen in elderly patients
It has been suggested that SVD is part of a multisystem disorder and several systematic reviews have addressed the hypothesis of a potential link between small vessel disease of the heart brain and kidneys Cerebral SVD is prevalent in the aging population causing cognitive impairment dementia and an increased risk of stroke and cerebral hypoperfusion is an acknowledged cause of vascular dementia and a possible cause of Alzheimers disease Further cognitive impairment within multiple cognitive domains is highly prevalent in heart failure and is associated to an increased risk of dementia The link between heart failure and dementia may be due to multisystem SVD although a direct link between the two is possible
Among other known risk factors such as age hypertension and female sex diabetes is a major cause of SVD and is linked to coronary heart disease as well as cognitive impairment The diagnosis of cerebral SVD relies on MRI detecting infarctions haemorrhages microbleeds and ischemic white matter changes ie Fazekas score In contrast perfusion PET is used to image myocardial perfusion in patients with coronary SVD and coronary SVD is recognized as a part of the pathophysiology in angina coronary artery disease and heart failure Perfusion PET before and after adenosine-induced vasodilation allows for measuring the myocardial flow reserve MFR ie perfusion capacity which in the absence of regional perfusion defects is a measure of coronary SVD Prof Eva Prescott have recently shown that reduced MFR obtained by 82Rb PET is a strong predictor of future microvascular events and all-cause mortality
Exercise is well known to improve cognitive health but professor Carl-Johan Boraxbekk has shown that the effect on cognitive performance may be dependent on the initial cerebrovascular status as patients with moderate to severe white matter changes did not improve after a 6 months physical activation intervention in contrast to patients with mild changes Yet it is possible to improve brain function in diabetic patients through either dietary or exercise interventions
Systemic SVD is measured as cerebral SVD reduced brain perfusion during acetazolamide-induced vasodilation and coronary SVD reduced heart perfusion during adenosine-induced vasodilation The researchers anticipate that patients with type 2 dabetes have reduced perfusion capacity of the brain and heart correlating to reduced cognition and cardiorespiratory fitness VO2-max
It has been suggested that SVD is part of a multisystem disorder and several systematic reviews have addressed the hypothesis of a potential link between small vessel disease of the heart brain and kidneys Cerebral SVD is prevalent in the aging population causing cognitive impairment dementia and an increased risk of stroke and cerebral hypoperfusion is an acknowledged cause of vascular dementia and a possible cause of Alzheimers disease Further cognitive impairment within multiple cognitive domains is highly prevalent in heart failure and is associated to an increased risk of dementia The link between heart failure and dementia may be due to multisystem SVD although a direct link between the two is possible
Among other known risk factors such as age hypertension and female sex diabetes is a major cause of SVD and is linked to coronary heart disease as well as cognitive impairment The diagnosis of cerebral SVD relies on MRI detecting infarctions haemorrhages microbleeds and ischemic white matter changes ie Fazekas score In contrast perfusion PET is used to image myocardial perfusion in patients with coronary SVD and coronary SVD is recognized as a part of the pathophysiology in angina coronary artery disease and heart failure Perfusion PET before and after adenosine-induced vasodilation allows for measuring the myocardial flow reserve MFR ie perfusion capacity which in the absence of regional perfusion defects is a measure of coronary SVD Prof Eva Prescott have recently shown that reduced MFR obtained by 82Rb PET is a strong predictor of future microvascular events and all-cause mortality
Exercise is well known to improve cognitive health but professor Carl-Johan Boraxbekk has shown that the effect on cognitive performance may be dependent on the initial cerebrovascular status as patients with moderate to severe white matter changes did not improve after a 6 months physical activation intervention in contrast to patients with mild changes Yet it is possible to improve brain function in diabetic patients through either dietary or exercise interventions
Systemic SVD is measured as cerebral SVD reduced brain perfusion during acetazolamide-induced vasodilation and coronary SVD reduced heart perfusion during adenosine-induced vasodilation The researchers anticipate that patients with type 2 dabetes have reduced perfusion capacity of the brain and heart correlating to reduced cognition and cardiorespiratory fitness VO2-max
Detailed Description:
The goal of this clinical trial is to compare baseline measurements relevant to microvascular disease between patients with diabetes and increased risk of microvascular disease with healthy age-matched control
The researchers wish to examine if small vessel disease is a disease that affects several organs at once in the same individuals by examining it in the brain and heart in the same participants The researchers will also test if cardiorespiratory conditioning VO2-max blood perfusion to the heart and brain and cognitive performance are correlated in patients with microvascular disease
To adress these aims the researchers have defined the following assumptions that they will refute or confirm through this study
Patients with type 2 diabetes and increased risk of small vessel disease have significantly reduced perfusion capacity of the brain and heart compared to healthy controls as part of a multisystem disease
Perfusion capacity of the brain and heart the cardiorespiratory fitness level of the subjects and cognitive performance are directly linked
48 patients with diabetes and 24 healthy age-matched controls will undergo baseline testing that include
Cardiopulmonal Exercise Test CPET to determine cardiopulmonal conditioning VO2-max
Isometric knee strength if logistically possible
Echocardiography
Blood perfusion capacity of the heart and brain via 15OH2O-PET scans
Brain MRI to determine structural damages
Blood samples for basic health check relevant to inclusion exclusion and safety and blood samples looking at endothelial and neurological damage for a biobank
Cognitive testing SCIP-D and CANTAB
Afterwards the researchers will compare the results between the two groups and see if there is a correlation between VO2-max blood perfusion to the heart and brain and cognitive performance
The researchers wish to examine if small vessel disease is a disease that affects several organs at once in the same individuals by examining it in the brain and heart in the same participants The researchers will also test if cardiorespiratory conditioning VO2-max blood perfusion to the heart and brain and cognitive performance are correlated in patients with microvascular disease
To adress these aims the researchers have defined the following assumptions that they will refute or confirm through this study
Patients with type 2 diabetes and increased risk of small vessel disease have significantly reduced perfusion capacity of the brain and heart compared to healthy controls as part of a multisystem disease
Perfusion capacity of the brain and heart the cardiorespiratory fitness level of the subjects and cognitive performance are directly linked
48 patients with diabetes and 24 healthy age-matched controls will undergo baseline testing that include
Cardiopulmonal Exercise Test CPET to determine cardiopulmonal conditioning VO2-max
Isometric knee strength if logistically possible
Echocardiography
Blood perfusion capacity of the heart and brain via 15OH2O-PET scans
Brain MRI to determine structural damages
Blood samples for basic health check relevant to inclusion exclusion and safety and blood samples looking at endothelial and neurological damage for a biobank
Cognitive testing SCIP-D and CANTAB
Afterwards the researchers will compare the results between the two groups and see if there is a correlation between VO2-max blood perfusion to the heart and brain and cognitive performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None