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临床试验/NCT05740514
NCT05740514招募中不适用

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

McMaster University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
168
试验地点
1
主要终点
The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Twelve-week Exercise

Experimental

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

干预措施: Exercise (Behavioral)

One-week Detraining

Experimental

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

干预措施: De-training (Behavioral)

Four-week Re-training

Experimental

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

干预措施: Exercise (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description)(Seventeen weeks following study initiation)
  • 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 initiation)
  • 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 initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Hawke

Professor

McMaster University

研究点 (1)

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