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Healthy Outcomes for Muscle with Exercise in T1D

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05740514
Acronym
HOME T1D
Enrollment
168
Registered
2023-02-23
Start date
2023-10-01
Completion date
2027-11-30
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

BEHAVIORALExercise

Exercise training.

BEHAVIORALDe-training

Exercise de-training via unilateral knee immobilization.

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Study subjects will participate in a twelve-week exercise program. Following this time, a one-week detraining period will ensue. Following this detraining period, study subjects will re-engage in a four-week exercise program.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frameDescription
The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)Twelve weeks following study initiationFollowing 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.
The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)Thirteen weeks following study initiationFollowing 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.
The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)Seventeen weeks following study initiationFollowing 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.

Countries

Canada

Contacts

Primary ContactThomas J Hawke, PhD
hawke@mcmaster.ca905-525-9140
Backup ContactIrena A Rebalka, PhD
rebalka@mcmaster.ca905-525-9140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026