Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04840095
Status:
RECRUITING
Last Update Posted:
2023-01-12
First Post:
2021-04-07
Brief Title:
Dynamic Connectivity Under Metabolic Constraints
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Dynamic Connectivity Under Metabolic Constraints
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
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:
In this study we investigate the impact of insulin resistance on the acceleration of brain aging and test 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 During each session we measure the impact of fuel glucose in one session ketones in the other on brain metabolism and associated functioning For Arms 1-2 our primary experimental measure is functional magnetic resonance imaging fMRI which we will use 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 we use simultaneous magnetic resonance spectroscopypositron-emission tomography MRPET 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 we 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 we measure brain response to cognitive load transitioning from resting-state to spatial reasoning through a Tetris task To assess effects of increased metabolic supply we 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 we 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 we measure brain response to cognitive load transitioning from resting-state to spatial reasoning through a Tetris task To assess effects of increased metabolic supply we 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