Clinical trial NCT05740514: Healthy Outcomes for Muscle with Exercise in T1D
Official title: Targeting Vascular and Skeletal Muscle Health to Improve Quality of Life in Males and Females with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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

Primary outcomes:
measure: The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)
timeFrame: At time of study start (baseline characteristics)
Secondary outcomes:
measure: The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
timeFrame: Twelve weeks following study initiation
measure: The acute effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
timeFrame: Thirteen weeks following study initiation
measure: The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)
timeFrame: Seventeen weeks following study initiation
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Thomas J Hawke, PhD
role: PRINCIPAL_INVESTIGATOR
References: