Heat Therapy in Type 2 Diabetes

NCT06596967 | Recruiting Phase 1 DMC

• 2 other identifiers: 2024-854P30DK097512
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test whether home-based heat therapy (HT) can improve the health of older adults with type 2 diabetes (T2D). T2D is common in older adults and can lead to severe issues such as heart disease, disability, and early death. While regular exercise is known to help manage T2D, many people with the condition find it difficult to stay active. This study explores HT as a simple, non-invasive treatment that may offer similar benefits. Participants will wear special leg sleeves that deliver heat to their legs for 90 minutes each day at home over 12 weeks. The study\'s primary goal is to assess whether HT treatment at home is feasible and safe to use. We hypotesize that people with diabetes who receive heat therapy will have better blood sugar control, stronger legs, less body fat, and improved ability to walk, along with lower blood pressure. If successful, HT could offer a new option for people with T2D to manage their condition, especially for those who struggle with regular exercise. This research could lead to larger studies and help provide a practical way to improve health and quality of life for older adults with diabetes.

Conditions

Type 2 Diabetes

Keywords

heat therapy; type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Compliance

  A built-in timer inside the pump that is inaccessible to participants will provide one assessment of patient compliance with the therapy. Compliance will be determined by dividing the number of hours of HT recorded use by the required hours. In addition, patients in both groups will receive a logbook to record their treatment sessions.

  From enrollment to the end of treatment at 12 weeks

• Completion rate

  Completion rates will be defined as the number of patients attending the follow-up assessments.

  From enrollment to the end of treatment at 12 weeks

• Safety

  The study coordinator will call patients weekly to record the occurrence of symptoms, such as faintness or dizziness after exposure to the therapy, and changes in medical status . Adverse events (AEs) will be tracked throughout the study and used as a surrogate for safety-related outcomes.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (7)

• Change in Insulin sensitivity

  Baseline and 12-week follow-up

• Change in blood pressure

  Baseline and 12-week follow-up

• Change in body composition

  Baseline and 12-week follow-up

• Change in 6-minute walk distance

  Baseline and 12-week follow-up

• Change in peak torque of the knee extensors

  Baseline to 12-week follow-up

Study Arms (2)

SHAM

SHAM COMPARATOR

In the sham group, water at 33ºC will be circulated through the leg sleeves.

Device: Sham

HEAT THERAPY

EXPERIMENTAL

In the leg heat therapy group, water at 42ºC will be circulated through the leg sleeves.

Device: Heat therapy

Interventions

Heat therapy DEVICE

Participants will be provided with a heat therapy system comprising a controller unit with a water pump and air pump, a portable heater, and leg sleeves featuring inner-layer water-circulating pads and an outer layer of inflatable bladders. The system is engineered to facilitate effective heat transfer through gentle pneumatic inflation, accommodating various limb dimensions. The heater will be set to warm the water to 42°C. Participants will be instructed to administer the therapy for 90 minutes daily in a seated or supine position.

Also known as: Leg heating

HEAT THERAPY

Sham DEVICE

Participants will be provided with a heat therapy system comprising a controller unit with a water pump and air pump, a portable heater, and leg sleeves featuring inner-layer water-circulating pads and an outer layer of inflatable bladders. The system is engineered to facilitate effective heat transfer through gentle pneumatic inflation, accommodating various limb dimensions. The heater will warm the water to 33°C. Participants will be instructed to administer the therapy for 90 minutes daily in a seated or supine position.

SHAM

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 55 and older
• Type 2 Diabetes (documented by chart review, presence of treatment for type 2 Diabetes, fasting plasma glucose equal or greater than 126 mg/dL or A1C equal or greater than 6.5%).

You may not qualify if:

• (1) HbA1c \<6.5% or \>9.0%, (2) body mass index \> 40 kg/m2, (3) insulin-dependent Type 1 Diabetes Mellitus, (4) incident cardiovascular events in the last year (heart attack, stroke), (5) symptomatic coronary artery disease and/or heart failure, (6) uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>110 mmHg), (7) hypotension (resting systolic BP \< 90 mmHg), (8) use of walking aid other than a cane, (9) active cancer, (10) impaired thermal sensation in the legs, (11) unable to fit into water-circulating garments, (12) orthopedic complications that preclude completion of physical function tests, (13) contraindications or inability to undergo a DXA scan, including implants, devices, or other foreign material, and inability to attain correct position and/or remain motionless for the measurement.

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Central Study Contacts

Bruno Tesini Roseguini, PhD

CONTACT

(765) 496-2612; brosegui@purdue.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 3, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)