Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04106882
Status:
UNKNOWN
Last Update Posted:
2019-09-27
First Post:
2019-09-17
Brief Title:
Dynamic Connectivity Under Metabolic Constraints
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Dynamic Connectivity Under Metabolic Constraints
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are studying the impact of insulin resistance on the acceleration of brain aging and testing whether increased neuron insulin resistance can be counteracted by utilization of alternate metabolic pathways eg ketones rather than glucose This study has three Arms which together provide synergistic data For all three Arms subjects are tested in a within-subjects design that consists of 2-3 testing sessions 1-14 days apart and counter-balanced for order Impact of fuel glucose in one session ketones in the other on brain metabolism and associated functioning is measured during each session For Arms 1-2 the primary experimental measure is functional magnetic resonance imaging fMRI which is used to trace the self-organization of functional networks following changes in energy supply and demand Arm 1 tests the impact of endogenous ketones produced by switching to a low carbohydrate diet while Arm 2 tests the impact of exogenous ketones consumed as a nutritional supplement For Arm 3 simultaneous magnetic resonance spectroscopypositron-emission tomography MRPET is used to quantify the impact of exogenous ketones on production of glutamate and GABA key neurotransmitters
Subjects will be given the option to participate in more than one of the Arms but doing so is not expected nor required
Prior to scans subjects will receive a clinician-administered History and Physical HP which includes vital signs an oral glucose tolerance test OGTT and the comprehensive metabolic blood panel These will be used to assess diabetes kidney disease and electrolytes If subjects pass screening they will be provided the option to participate in one or more Arms which include neuroimaging To provide a quantitative measure of time-varying metabolic activity throughout the scan based upon quantitative models of glucose and ketone regulation as well as to be able to implement safety stopping rules see below the investigators will obtain pin-prick blood samples three times prior to the scan following consumption of the glucose or ketone drink and following completion of the scan To assess effects of increased metabolic demand the investigators measure brain response to cognitive load transitioning from resting-state to spatial reasoning through a spatial navigation video task To assess effects of increased metabolic supply the investigators measure brain response to glucose or ketone bolus
Subjects will be given the option to participate in more than one of the Arms but doing so is not expected nor required
Prior to scans subjects will receive a clinician-administered History and Physical HP which includes vital signs an oral glucose tolerance test OGTT and the comprehensive metabolic blood panel These will be used to assess diabetes kidney disease and electrolytes If subjects pass screening they will be provided the option to participate in one or more Arms which include neuroimaging To provide a quantitative measure of time-varying metabolic activity throughout the scan based upon quantitative models of glucose and ketone regulation as well as to be able to implement safety stopping rules see below the investigators will obtain pin-prick blood samples three times prior to the scan following consumption of the glucose or ketone drink and following completion of the scan To assess effects of increased metabolic demand the investigators measure brain response to cognitive load transitioning from resting-state to spatial reasoning through a spatial navigation video task To assess effects of increased metabolic supply the investigators measure brain response to glucose or ketone bolus
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None