Feasibility of Improving Glycemia With Heat Therapy to Prevent AD

NCT06023407 | Enrolling By Invitation DMC

• 2 other identifiers: STUDY00147285R01AG081304
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging; Alzheimer Disease; Metabolic Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 weeks

Secondary Outcomes (1)

• Fluorodeoxyglucose (FDG) positron emission tomography (PET) Metabolism (Standard Uptake Value Ratio)

  10 weeks

Study Arms (2)

Heat therapy Group

EXPERIMENTAL

40.5°C water

Other: Water Immersion Heat Therapy

Thermoneutral Control Group

SHAM COMPARATOR

36°C water

Other: Water Immersion Heat Therapy

Interventions

Water Immersion Heat Therapy OTHER

10-weeks of 3 days per week in 1 of the 2 arms

Heat therapy Group; Thermoneutral Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Univeristy of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Metabolic Diseases

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jill Morris

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Primary Investigators will be blinded to participants group. Due to the type of intervention we are unable to blind participant or certain members of the study team
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 allocation to either heat therapy intervention or thermoneutral control group

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)