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NCT05740514Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
168 (estimated)
First submitted
25 Jan 2023
Start date
1 Oct 2023
Primary completion date
Nov 2027
Lead sponsor
McMaster University
NCT number
NCT05740514

What you commit to

  • Study type: Interventional
  • Planned participants: 168
  • From 1 Oct 2023 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic use of anti-inflammatory, glucocorticoid, or other pain-relief medication

Other illness

  • History of daily cannabis, tobacco, or nicotine use within six months of study initiation
  • Type 2 diabetes
  • Health conditions that put the subject at risk to participate in exercise during this study

Other

  • BMI \>30kg/m2
  • Prediabetes
  • Atypical or Grade 2b diabetic sensorimotor polyneuropathy
  • More than one lifetime event of hospitalization for diabetic ketoacidosis

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McMaster University
Coordinator of this site? Confirm its status
HamiltonCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.