Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023407
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-02
First Post:
2023-08-28
Brief Title:
Feasibility of Improving Glycemia With Heat Therapy to Prevent AD
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Feasibility of Improving Glycemia With Heat Therapy to Prevent AD
Status:
ENROLLING_BY_INVITATION
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:
FIGHT-AD
Brief Summary:
The investigators will determine if heat therapy can improve blood Aim 1 and brain Aim 2 glucose metabolism in cognitively healthy older adults 65 who are at risk for AD The investigators will also examine the degree to which changes in blood and brain glucose metabolism track together and explore several additional potential mechanisms that are critical to understanding the brain benefits of heat therapy Aim 3 These aims will provide a comprehensive understanding of the impact of heat therapy on whole body metabolic function and brain health
Detailed Description:
Aim 1 Examine the effects of heat therapy on blood glucose regulation in older adults at risk for AD The Investigators will determine the ability of 10 weeks of heat therapy 3 daysweek to improve blood glucose regulation in older adults at risk for AD Our primary outcome measures will be change in glycated hemoglobin HbA1c and change in insulin sensitivity index ISI assessed pre- vs post-intervention The Investigators will also perform continuous glucose monitoring for 7 days prior to and following the intervention as well as monitor dietary patterns during the intervention The Investigators hypothesize that 10 weeks of heat therapy will lower HbA1c values and improve ISI outcomes
Aim 2 Test the effect of heat therapy on brain glucose metabolism To date no studies have examined the impact of heat therapy on brain glucose metabolism Here The Investigators will determine the effect of 10 weeks of heat therapy on brain glucose metabolism in older adults at risk for AD Our primary outcome measure will be change in 18F fluorodeoxyglucose FDG global standardized uptake value ratio SUVR pre- vs post- heat therapy The Investigators hypothesize that individuals will improve increase global cerebral glucose metabolism following 10 weeks of heat therapy The Investigators further hypothesize that the degree of change in blood glucose metabolism will track with change in brain glucose metabolism
Aim 3 Explore the effect of heat therapy on fluid biomarkers proteostasis inflammation neuropathology and neuroimaging markers of brain health The Investigators will explore the effect of heat therapy on plasma markers of proteostasis HSPs inflammation CRP TNF IL-6 JNK and IKK and AD-related neuropathology AmyloidTauNeurodegeneration ATN measures markers in plasma at baseline and following 10 weeks of heat treatment The Investigators will also obtain MRI measures of resting state metabolism brain blood flow and oxygen uptake for preliminary characterization of intervention-related changes The Investigators hypothesize that proteostasis inflammation and AD neuropathology will be beneficially affected by heat treatment The Investigators further hypothesize that the team will observe benefits in MRI-related brain outcomes
Aim 2 Test the effect of heat therapy on brain glucose metabolism To date no studies have examined the impact of heat therapy on brain glucose metabolism Here The Investigators will determine the effect of 10 weeks of heat therapy on brain glucose metabolism in older adults at risk for AD Our primary outcome measure will be change in 18F fluorodeoxyglucose FDG global standardized uptake value ratio SUVR pre- vs post- heat therapy The Investigators hypothesize that individuals will improve increase global cerebral glucose metabolism following 10 weeks of heat therapy The Investigators further hypothesize that the degree of change in blood glucose metabolism will track with change in brain glucose metabolism
Aim 3 Explore the effect of heat therapy on fluid biomarkers proteostasis inflammation neuropathology and neuroimaging markers of brain health The Investigators will explore the effect of heat therapy on plasma markers of proteostasis HSPs inflammation CRP TNF IL-6 JNK and IKK and AD-related neuropathology AmyloidTauNeurodegeneration ATN measures markers in plasma at baseline and following 10 weeks of heat treatment The Investigators will also obtain MRI measures of resting state metabolism brain blood flow and oxygen uptake for preliminary characterization of intervention-related changes The Investigators hypothesize that proteostasis inflammation and AD neuropathology will be beneficially affected by heat treatment The Investigators further hypothesize that the team will observe benefits in MRI-related brain outcomes
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 |
|---|---|---|---|
| R01AG081304 | NIH | None | httpsreporternihgovquickSearchR01AG081304 |