Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-29 @ 9:53 PM
Study NCT ID:
NCT06596967
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Therapy in Type 2 Diabetes
Sponsor:
Purdue University
Organization:
Study Overview
Official Title:
Home-based Heat Therapy in Older Adults with Type 2 Diabetes: a Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
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.
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.
Detailed Description:
Our objective in this proposal is to conduct a pilot randomized, sham-controlled trial to establish the feasibility, acceptability, and safety of home-based leg HT for 12 weeks in older individuals with T2D. We will also examine changes in glucose regulation, body composition, blood pressure, skeletal muscle strength, and physical function. Individuals will be asked to apply the treatment daily for 90 min using water-circulating sleeves perfused with warm water Our working hypotheses are that diabetic individuals receiving HT will manifest: 1) improved blood glucose regulation, 2) enhanced leg strength and power, 3) lower body fat content, and 4) improved walking tolerance21 and lower blood pressure.
We propose the following specific aims:
AIM 1: Establish the feasibility of home-based HT for older individuals with T2D. The primary outcomes are compliance with the HT regimen, measured by a hidden timer, completion rates, device safety, and usability.
AIM 2: Examine the effects of HT on blood glucose regulation in older adults with T2D. We will assess the change in glycated hemoglobin (HbA1c) and insulin sensitivity index (Matsuda insulin sensitivity index) between baseline and the 12-week follow-up. Glucose, insulin, and HbA1c will be measured in the Translation Core.
AIM 3: Evaluate the effect of HT on lower-extremity functioning and body composition in older adults with T2D. We will assess changes in walking endurance (6-minute walk distance), leg muscle strength and power (isokinetic dynamometry), lower extremity functioning (Short Physical Performance Battery), and body composition (Dual-energy X-ray absorptiometry).
We propose the following specific aims:
AIM 1: Establish the feasibility of home-based HT for older individuals with T2D. The primary outcomes are compliance with the HT regimen, measured by a hidden timer, completion rates, device safety, and usability.
AIM 2: Examine the effects of HT on blood glucose regulation in older adults with T2D. We will assess the change in glycated hemoglobin (HbA1c) and insulin sensitivity index (Matsuda insulin sensitivity index) between baseline and the 12-week follow-up. Glucose, insulin, and HbA1c will be measured in the Translation Core.
AIM 3: Evaluate the effect of HT on lower-extremity functioning and body composition in older adults with T2D. We will assess changes in walking endurance (6-minute walk distance), leg muscle strength and power (isokinetic dynamometry), lower extremity functioning (Short Physical Performance Battery), and body composition (Dual-energy X-ray absorptiometry).
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30DK097512 | NIH | None | https://reporter.nih.gov/quic… | View |