What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes that improve metabolic functions and vascular endothelial function include lifestyle interventions, SGLT2 inhibitors, and GLP-1 receptor agonists. Lifestyle interventions such as diet and exercise can lead to weight loss and improved glycemic control but may cause hypoglycemia if not monitored properly. SGLT2 inhibitors can improve cardiovascular outcomes but have been associated with an increased risk of genital infections and, in some cases, amputations. GLP-1 receptor agonists also improve cardiovascular outcomes and aid in weight loss but may cause gastrointestinal issues such as nausea and vomiting.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that improve metabolic functions and vascular endothelial function. Notably, GLP-1 receptor agonists such as liraglutide and exenatide have been approved due to their ability to lower blood glucose levels and provide cardiovascular benefits. Additionally, SGLT2 inhibitors like canagliflozin have been approved for their role in improving glycemic control and reducing cardiovascular events. These treatments align with the goals of improving metabolic functions and vascular health, similar to the benefits observed with heat therapy.

What other types of research exist?

Promising novel alternatives to heat therapy for T2DM patients include: 1) Sodium-glucose co-transporter 2 inhibitors (SGLT2-i) like dapagliflozin, which have shown improvements in endothelial function and reductions in cardiovascular events. 2) Glucagon-like peptide-1 receptor agonists (GLP1-RA), which improve endothelial function, lower vascular inflammation, and reduce cardiovascular events. Both therapies offer significant metabolic and vascular benefits for T2DM patients.

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Heat Therapy for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 45-75 years

Be older than 18 years old

Must not have

Class 3 obesity

Hypertension not controlled by medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 weeks

Summary

This trial will investigate if heat therapy can help people with type 2 diabetes. The study will see if regular heat exposure over a few months improves how their bodies handle fats and sugars and if it benefits their blood vessels. This approach is being tested because current medications alone are not enough to reduce their high risk of heart disease. Heat therapy has been found effective in improving glycaemic control in patients with type 2 diabetes.

Who is the study for?

This trial is for men and women aged 45-75 with type 2 diabetes diagnosed at least a year ago, who have been on stable medication for the past 12 weeks. It's not suitable for those with severe heart, kidney or lung diseases, very high obesity (Class 3), uncontrolled hypertension, serious nerve or eye damage from diabetes, those using insulin therapy, or with very high blood fat or cholesterol levels.

What is being tested?

The study is exploring whether sitting in hot water can improve heart health and sugar metabolism in people with type 2 diabetes. Participants will undergo heat therapy sessions over a period of 12 weeks to see if it helps manage fatty acids after eating, improves insulin sensitivity and benefits the lining of their blood vessels.

What are the potential side effects?

Potential side effects may include discomfort due to heat exposure such as sweating or dizziness. Long-term effects are unknown but could involve changes in skin condition due to frequent hot water immersion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is 40 or higher.

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My high blood pressure is not controlled by medication.

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I am on insulin therapy.

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I have severe nerve pain or vision problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Arterial stiffness

Blood pressure

Ischemic handgrip exercise

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HeatExperimental Treatment1 Intervention

Participants will immerse their feet in a foot bath with water maintained at 42°C

Group II: ThermoneutralPlacebo Group1 Intervention

Participants will immerse their feet in a foot bath with water maintained at 36°C

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include insulin therapy, GLP-1 receptor agonists, and SGLT2 inhibitors. Insulin therapy helps to lower blood glucose levels by facilitating the uptake of glucose into cells. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which collectively improve blood glucose control and promote weight loss. SGLT2 inhibitors reduce blood glucose by preventing glucose reabsorption in the kidneys, leading to its excretion in urine. These treatments are crucial for Type 2 Diabetes patients as they not only manage hyperglycemia but also improve metabolic functions and vascular health, reducing the risk of cardiovascular complications.

Evaluations of retinopathy in the VA Cooperative Study on Glycemic Control and Complications in Type II Diabetes (VA CSDM). A feasibility study.