Recruiting

Exercise

Sponsor:

McMaster University

Code:

NCT05740514

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Exercise

De-training

Study Details

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.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT05740514

Start date

Oct 1, 2023

Status verified date

Dec, 2024

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Twelve-week Exercise

Study participants will participate in an exercise program consisting of aerobic and resistance exercise. This arm will last twelve weeks.

experimental: One-week Detraining

Study participants will undergo unilateral knee immobilization for a one-week period.

experimental: Four-week Re-training

Study participants will once again participate in an exercise program consisting of aerobic and resistance exercise. This arm will last four weeks.

Interventions

Exercise

Exercise training.

De-training

Exercise de-training via unilateral knee immobilization.

Primary outcome measure

  • The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description) [ Time Frame: At time of study start (baseline characteristics) ]

Central Contacts and Locations

Central contacts

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

More Information

Sponsor

McMaster University

Last update posted

Dec 5, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McMaster University on 2024-12-05.