Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373016
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-02-07
Brief Title:
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar The main question it aims to answer is how glucose and ketones each affect the brains response to risk and reward Participants will be asked to provide blood to assess baseline measures of how the body uses energy and then to receive two MRI scan sessions on separate days During each MRI scan session participants will play three games from which they can win money before and after drinking glucose on one day or ketones on the other day Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy and to test how the brains use of energy affects behavior
Detailed Description:
The purpose of the study is to understand the impact of glucose vs ketones on brain metabolism and function in individuals with bipolar The specific aims are to examine
1 Stability of the brains signaling over time
2 Regulation of the neural circuits that process risk
3 Regulation of the neural circuits that process reward
Study Procedures
Baseline Blood Samples Blood will be taken at Massachusetts General Hospital Translational and Clinical Research Center to measure baseline levels of several key variables associated with metabolic function These variables include insulin resistance HbA1c thyroid function T3 T4 TSH the efficiency of the tricarboxylic acid TCA cycle lactatepyruvate energy sensing AMPK mitochondrial regulation and inflammation IL-6 tumor necrosis factor TNF-alpha
Scanning Procedure The scanning procedure for magnetic resonance MR imaging on each day will include 1 functional MR fMRI during cognitive task three games 2 MR spectroscopy MRS and 3 resting state Following the scan the participant will drink either glucose or ketones and repeat 1-3 above
Blood glucose and ketone monitoring Using a finger-prick test investigators will measure blood glucose and ketones three times during each scan session This will be done immediately before starting the scan session 10 minutes after consuming either glucose or ketones and immediately after ending the scan session Mild temporary paindiscomfort may occur at the site of finger-prick for blood glucose and ketone concentration measurements pre-scan post-drink and post-scan but no other side effects are expected from this test Precision Xtra is a standard over-the-counter blood glucose and ketone monitoring system routinely self-administered by diabetic patients Participants fingers will be sanitized with alcohol wipes and a fresh lancet will be used to perform each finger prick test
1 Stability of the brains signaling over time
2 Regulation of the neural circuits that process risk
3 Regulation of the neural circuits that process reward
Study Procedures
Baseline Blood Samples Blood will be taken at Massachusetts General Hospital Translational and Clinical Research Center to measure baseline levels of several key variables associated with metabolic function These variables include insulin resistance HbA1c thyroid function T3 T4 TSH the efficiency of the tricarboxylic acid TCA cycle lactatepyruvate energy sensing AMPK mitochondrial regulation and inflammation IL-6 tumor necrosis factor TNF-alpha
Scanning Procedure The scanning procedure for magnetic resonance MR imaging on each day will include 1 functional MR fMRI during cognitive task three games 2 MR spectroscopy MRS and 3 resting state Following the scan the participant will drink either glucose or ketones and repeat 1-3 above
Blood glucose and ketone monitoring Using a finger-prick test investigators will measure blood glucose and ketones three times during each scan session This will be done immediately before starting the scan session 10 minutes after consuming either glucose or ketones and immediately after ending the scan session Mild temporary paindiscomfort may occur at the site of finger-prick for blood glucose and ketone concentration measurements pre-scan post-drink and post-scan but no other side effects are expected from this test Precision Xtra is a standard over-the-counter blood glucose and ketone monitoring system routinely self-administered by diabetic patients Participants fingers will be sanitized with alcohol wipes and a fresh lancet will be used to perform each finger prick test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2023005 | OTHER_GRANT | Baszucki Foundation | None |