Healthy Outcomes for Muscle with Exercise in T1D
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, De-training.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Targeting Vascular and Skeletal Muscle Health to Improve Quality of Life in Males and Females with Type 1 Diabetes
Overview
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.
Interventions
- Behavioral Exercise
Exercise training. - Behavioral De-training
Exercise de-training via unilateral knee immobilization.
Primary outcome measures
- The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description) [Time frame: At time of study start (baseline characteristics)]
Secondary outcome measures (3)
- 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]
- 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]
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Canada · 1 center
- McMaster University — Hamilton
Publications
- Rebalka IA, Noguchi KS, Bulyovsky KR, Badour MI, Juracic ES, Barrett K, Brahmbhatt A, Al-Khazraji B, Punthakee Z, Perry CGR, Kumbhare DA, MacDonald MJ, Hawke TJ. Targeting skeletal muscle health with exercise in people with type 1 diabetes: A protocol for HOMET1D, a prospective observational trial with matched controls. PLoS One. 2024 May 22;19(5):e0303448. doi: 10.1371/journal.pone.0303448. eColl PMID 38776307
Identifiers
NCT: NCT05740514 · 15516