Healthy AgingFIGHT-ADNCT06023407
Feasibility of Improving Glycemia With Heat Therapy to Prevent AD
A study testing Water Immersion Heat Therapy in people with Healthy Aging and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Healthy Aging, Alzheimer Disease, Metabolic Disease
- What is being tested?
- Water Immersion Heat Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and older
- Stable medication doses (>1 month)
- Post-menopausal
- Clinical Dementia Rating (CDR) of 0
- History of or current metabolic impairment (i.e. metabolic syndrome, pre-diabetes, Type 2 Diabetes, etc)
Who cannot join
- Excluded from or unable to complete an MRI scan. MRI compatible pacemakers will require cardiologist clearance prior to enrolling.
- ACSM Risk score stratification of "High" unless cleared by a physician prior to participation.
- Myocardial infarction or symptoms of coronary artery disease in the last 2 years.
- History of or current diagnosis of disorders with the potential to impair cognition (i.e. AD, Parkinson's disease, stroke (defined as clinical episode w/ neuroimaging evidence in appropriate area to explain symptoms)).
- Insulin-dependent (Type 1) Diabetes Mellitus.
- Clinically significant chronic disease such as cancer, HIV, or acquired immunodeficiency syndrome.
Show all 10Show fewer
- Clinically significant depressive symptoms that may impair cognition, use of psychoactive and investigational medications, and significant visual or auditory impairment.
- Orthopedic complications that would preclude individuals from safely entering a hot tub.
- Untreated hypothyroidism or diseases associated with heat intolerance (i.e. Graves disease, etc).
- Contraindication for temperature pill ingestion (i.e. inflammatory bowel disease, diverticulitis or related).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Univeristy of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the 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 days/week) 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 (HSP's), inflammation (CRP, TNF, IL-6, JNK and IKK) and AD-related neuropathology (Amyloid/Tau/Neurodegeneration; A/T/N 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.
- Conditions
- Healthy Aging, Alzheimer Disease, Metabolic Disease
- Being tested
- Water Immersion Heat Therapy
- Medical subject headings
- Alzheimer Disease, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water Immersion Heat TherapyOther
10-weeks of 3 days per week in 1 of the 2 arms
| Study group | Role | What they receive |
|---|---|---|
| Heat therapy Group | Experimental | 40.5°C water Receives: Other: Water Immersion Heat Therapy |
| Thermoneutral Control Group | Sham comparator | 36°C water Receives: Other: Water Immersion Heat Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months. below 5.7 %. Anyone with an HbA1c. A value of 5.7 % to 6.4 % is considered to be prediabetic, while diabetes can be diagnosed with a HbA1c of 6.5% or higher.
Measured: 10 weeks
Insulin sensitivity index
Using glucose and insulin from a the OGTT, an indices will be calculated for insulin sensitivity. The goal is to increase the insulin sensitivity. Minimum=0; No upper limit. Increasing value indicates improved outcomes.
Measured: 10 weeks
Secondary outcomes (1)
Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio)
FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) will be calculated from native-space region of interest (ROI).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start27 Feb 2024
- Primary completion29 Oct 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 allocation to either heat therapy intervention or thermoneutral control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jill Morris, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023407
- Sponsor's protocol ID
- STUDY00147285
- Other IDs
- R01AG081304
- Acronym
- FIGHT-AD
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geiger PC, Pennington JS, Kueck PJ, John CS, Mayfield HD, Kemna RE, Burns J, Vidoni E, Honea R, Li Y, Mahnken J, Morris JK. Heat therapy in individuals at risk for Alzheimer's disease-methods for a randomized controlled trial. Front Neurol. 2026 Jan 23;17:1736108. doi: 10.3389/fneur.2026.1736108. eCollection 2026.
PubMed 41657418
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Improving Glycemia With Heat Therapy to Prevent AD
- ClinicalTrials.gov ID
- NCT06023407
- Acronym / sponsor ID
- FIGHT-AD / STUDY00147285
- Conditions
- Healthy Aging, Alzheimer Disease, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 days/week) 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 (HSP's), inflammation (CRP, TNF, IL-6, JNK and IKK) and AD-related neuropathology (Amyloid/Tau/Neurodegeneration; A/T/N 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 1:1 allocation to either heat therapy intervention or thermoneutral control group
| Arm | Type | Receives |
|---|---|---|
| Heat therapy Group | Experimental | Other: Water Immersion Heat Therapy40.5°C water |
| Thermoneutral Control Group | Sham comparator | Other: Water Immersion Heat Therapy36°C water |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 and older
- Stable medication doses (>1 month)
- Post-menopausal
- Clinical Dementia Rating (CDR) of 0
- History of or current metabolic impairment (i.e. metabolic syndrome, pre-diabetes, Type 2 Diabetes, etc)
Key exclusion criteria (10 listed)
- Excluded from or unable to complete an MRI scan. MRI compatible pacemakers will require cardiologist clearance prior to enrolling.
- ACSM Risk score stratification of "High" unless cleared by a physician prior to participation.
- Myocardial infarction or symptoms of coronary artery disease in the last 2 years.
- History of or current diagnosis of disorders with the potential to impair cognition (i.e. AD, Parkinson's disease, stroke (defined as clinical episode w/ neuroimaging evidence in appropriate area to explain symptoms)).
- Insulin-dependent (Type 1) Diabetes Mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water Immersion Heat Therapy10-weeks of 3 days per week in 1 of the 2 arms | Other | Heat therapy Group, Thermoneutral Control Group |
Primary outcome
HbA1C
Time frame: 10 weeks
hemoglobin A1C (HbA1C) test is a blood test that shows what your average blood sugar (glucose) level was over the past two to three months. below 5.7 %. Anyone with an HbA1c. A value of 5.7 % to 6.4 % is considered to be prediabetic, while diabetes can be diagnosed with a HbA1c of 6.5% or higher.
Insulin sensitivity index
Time frame: 10 weeks
Using glucose and insulin from a the OGTT, an indices will be calculated for insulin sensitivity. The goal is to increase the insulin sensitivity. Minimum=0; No upper limit. Increasing value indicates improved outcomes.
1 secondary outcome
Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio)
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 41657418Geiger PC, Pennington JS, Kueck PJ, John CS, Mayfield HD, Kemna RE, Burns J, Vidoni E, Honea R, Li Y, Mahnken J, Morris JK. Heat therapy in individuals at risk for Alzheimer's disease-methods for a randomized controlled trial. Front Neurol. 2026 Jan 23;17:1736108. doi: 10.3389/fneur.2026.1736108. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jill Morris principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Immersion Heat Therapy in people with Healthy Aging and Alzheimer Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.