NCT05740514 Healthy Outcomes for Muscle with Exercise in T1D
| NCT ID | NCT05740514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2023-10-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Thomas J Hawke, PhD
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT05740514 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05740514 currently recruiting?
Yes, NCT05740514 is actively recruiting participants. Contact the research team at hawke@mcmaster.ca for enrollment information.
Where is the NCT05740514 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT05740514 clinical trial?
NCT05740514 is sponsored by McMaster University. The principal investigator is Thomas J Hawke, PhD at McMaster University. The trial plans to enroll 168 participants.
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