Healthy Outcomes for Muscle with Exercise in T1D (HOME T1D)

McMaster University

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Exercise; Behavioral: De-training

Study type: Interventional

Funder types: Other

Identifiers

NCT05740514

15516

Details and patient eligibility

About

Over 300,000 people in Canada suffer from Type 1 Diabetes (T1D), a chronic condition whose incidence rate has been increasing in Canada every year by 5.1% (higher than the global average). While exogenous insulin injections allow those with T1D to live, it is not a cure, and those with T1D develop severe complications (kidney failure, cardiovascular disease). Strategies to regress the development of these complications, minimize healthcare system burden, and save the lives of Canadians are urgently needed.

Undertaking regular exercise is an obvious strategy for those with T1D and has many well-established health benefits. Despite these benefits, adults with T1D exercise less frequently due to fear of severe hypoglycemia and a lack of knowledge of effective exercise strategies. Adding to this complexity, the investigators have recently shown that males and females elicit differential impairments in skeletal muscle metabolism in response to T1D. These differences may extend to the peripheral microvasculature and may lead to sexual dimorphism in the health benefits of exercise for those with T1D. Ultimately, developing a healthy muscle mass, including microvasculature, will help mitigate dysglycemic and dyslipidemic fluctuations and improve insulin sensitivity.

The overarching purpose of this proposed study is to determine the impact of T1D on human skeletal muscle and its microvasculature over the lifespan in males and females, and its responses to exercise training and detraining.

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age of 18-30 or 45-65
• Sedentary or recreationally active, as defined by self-reported activity levels below the recommended 150-minute minimum of moderate-to-vigorous intensity physical activity per week

Exclusion criteria

• Chronic use of anti-inflammatory, glucocorticoid, or other pain-relief medication
• History of daily cannabis, tobacco, or nicotine use within six months of study initiation
• BMI >30kg/m2
• Prediabetes
• Type 2 diabetes
• Health conditions that put the subject at risk to participate in exercise during this study
• Atypical or Grade 2b diabetic sensorimotor polyneuropathy
• More than one lifetime event of hospitalization for diabetic ketoacidosis

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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168 participants in 3 patient groups

Twelve-week Exercise

Experimental group

Description:

Study participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks.

Treatment:

Behavioral: Exercise

One-week Detraining

Experimental group

Description:

Study participants will undergo unilateral knee immobilization for a one-week period.

Treatment:

Behavioral: De-training

Four-week Re-training

Experimental group

Description:

Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks.

Treatment:

Behavioral: Exercise