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NCT Number: NCT05740514

Healthy Outcomes for Muscle with Exercise in T1D

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location status: Recruiting

Location contact

Irena A Rebalka, PhD

CONTACT

Maureen MacDonald, PhD

CONTACT

Rebecca Leone

CONTACT

[email protected]

905-525-9140

Thomas J Hawke, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Exercise training.

De-training

Behavioral

Exercise de-training via unilateral knee immobilization.

Primary outcomes

  1. The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)

    Time frame: At time of study start (baseline characteristics)

    Individuals with T1D as well as their age, sex, and BMI-matched control counterparts will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function. All metrics will be compared between individuals with T1D and their non-T1D counterparts.

Secondary outcomes

  1. The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

    Time frame: Twelve weeks following study initiation

    Following baseline assessments, study participants will undergo a combined aerobic and resistance training program for twelve weeks. Following twelve weeks of participation in this exercise program, all study participants will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function.

  2. The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

    Time frame: Thirteen weeks following study initiation

    Following completion of the aforementioned twelve week exercise program, study participants will undergo a seven-day detraining period consisting of unilateral knee immobilization using a hinged knee-joint immobilization brace. Immediately following this immobilization period, all study participants will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function.

  3. The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)

    Time frame: Seventeen weeks following study initiation

    Following completion of the aforementioned twelve week exercise program, study participants will undergo a seven-day detraining period consisting of unilateral knee immobilization using a hinged knee-joint immobilization brace. Four weeks after this immobilization period, all study participants will undergo various physiological assessments to evaluate their muscle health: strength/aerobic fitness testing, compartmental body composition assessment, blood analysis, glucose monitoring, muscle biopsy, motor neuron function evaluation, and assessments of muscle microvascular structure and function.

Study contacts

Contact information is provided by the study sponsor or research team.

Irena A Rebalka, PhD

CONTACT

[email protected]

905-525-9140 ext. 26868

Thomas J Hawke, PhD

CONTACT

[email protected]

905-525-9140 ext. 22372

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Targeting Vascular and Skeletal Muscle Health to Improve Quality of Life in Males and Females with Type 1 Diabetes

Acronym: HOME T1D

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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