Feasibility of Improving Glycemia With Heat Therapy to Prevent AD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Water Immersion Heat Therapy.
- Who it may be relevant to
- Registry conditions: Healthy Aging, Alzheimer Disease, Metabolic Disease. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Water Immersion Heat Therapy
10-weeks of 3 days per week in 1 of the 2 arms
Primary outcome measures
- HbA1C [Time frame: 10 weeks]
- Insulin sensitivity index [Time frame: 10 weeks]
Secondary outcome measures (1)
- Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio) [Time frame: 10 weeks]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Univeristy of Kansas Medical Center — Kansas City
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. PMID 41657418
Identifiers
NCT: NCT06023407 · STUDY00147285 · R01AG081304