Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109174
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2005-04-22
Brief Title:
MRS Measurement of Glutamate and GABA Metabolism in Brain
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
MRS Magnetic Resonance Spectroscopy Measurement of Glutamate and GABA Metabolism in Brain
Status:
RECRUITING
Status Verified Date:
2024-09-05
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:
This study will use magnetic resonance spectroscopy MRS to measure in the brain the transfer of 13C as it is naturally metabolized from glucose to specific chemical transmitters From this method we can measure the rate of production of an important excitatory neurotransmitter glutamate as well as an inhibitory neurotransmitter GABA
Detailed Description:
13C is a stable ie non-radioactive isotope of carbon with a natural abundance of 1 Following infusion of 13Cglucose andor 13Cacetate in vivo MRS magnetic resonance spectroscopy can monitor the rate of flux of the 13C atom from glucose andor acetate to glutamate to glutamine Thus this procedure can provide measure of glutamate GLU and glutamine GLN turnover in brain We have established parameters to obtain these measurements in nonhuman primate brain The current protocol seeks approval to optimize MRS parameters and to develop new MRS techniques for human brain using the GE 3T the Siemens 3T and the Siemens 7T device
Study population All subjects will be aged 18 65 years without serious medical illnesses and meet criteria listed in Section VI A
Design Subjects will receive either oral administration of 13Cglucose or an intravenous infusion of 13Cglucose andor 13Cacetate to approximately double their plasma glucose levels The plasma acetate level will remain within the physiological range observed in humans Lebon et al 2002 While lying in the 3T or 7T device serial data acquisitions will be obtained over 2 h to optimize the experimental conditions so as to measure the 13C signals from GLU GLN and other metabolisms in brain
Outcome measures The primary goal of this study is to measure GLUGLN turnover in brain With no additional data acquisition we can also obtain information on the synthesis of GABA the major inhibitory neurotransmitter in brain GLU is converted to GABA via the enzyme glutamic acid decarboxylase GAD While monitoring the transfer of 13C signal from GLU to GLN we can simultaneously measure the transfer of 13C signal from GLU to GABA and thereby measure the activity of GAD Li et al 2005 In addition to directly measure 13C signals 13C labeling to brain metabolites can also be measured indirectly by detecting proton MRS during infusion of 13Cglucose andor 13Cacetate
Study population All subjects will be aged 18 65 years without serious medical illnesses and meet criteria listed in Section VI A
Design Subjects will receive either oral administration of 13Cglucose or an intravenous infusion of 13Cglucose andor 13Cacetate to approximately double their plasma glucose levels The plasma acetate level will remain within the physiological range observed in humans Lebon et al 2002 While lying in the 3T or 7T device serial data acquisitions will be obtained over 2 h to optimize the experimental conditions so as to measure the 13C signals from GLU GLN and other metabolisms in brain
Outcome measures The primary goal of this study is to measure GLUGLN turnover in brain With no additional data acquisition we can also obtain information on the synthesis of GABA the major inhibitory neurotransmitter in brain GLU is converted to GABA via the enzyme glutamic acid decarboxylase GAD While monitoring the transfer of 13C signal from GLU to GLN we can simultaneously measure the transfer of 13C signal from GLU to GABA and thereby measure the activity of GAD Li et al 2005 In addition to directly measure 13C signals 13C labeling to brain metabolites can also be measured indirectly by detecting proton MRS during infusion of 13Cglucose andor 13Cacetate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-M-0144 | None | None | None |