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Идёт набор NCT05740514

Healthy Outcomes for Muscle with Exercise in T1D

Без фазы С лечением Diabetes Mellitus, Type 1

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Exercise, De-training.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Type 1. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое Exercise
    Exercise training.
  • Поведенческое De-training
    Exercise de-training via unilateral knee immobilization.

Первичные конечные точки

  • The effect of T1D on skeletal muscle health, quantified by physiological parameters (detailed in description) [Срок оценки: At time of study start (baseline characteristics)]
Вторичные конечные точки (3)
  • The effect of twelve weeks of exercise on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description) [Срок оценки: 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) [Срок оценки: Thirteen weeks following study initiation]
  • The effect of a detraining period on skeletal muscle health compared to baseline, quantified by physiological parameters (detailed in description) [Срок оценки: Seventeen weeks following study initiation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • McMaster University — Hamilton

Публикации

  • Rebalka IA, Noguchi KS, Bulyovsky KR, Badour MI, Juracic ES, Barrett K, Brahmbhatt A, Al-Khazraji B, Punthakee Z, Perry CGR, Kumbhare DA, MacDonald MJ, Hawke TJ. Targeting skeletal muscle health with exercise in people with type 1 diabetes: A protocol for HOMET1D, a prospective observational trial with matched controls. PLoS One. 2024 May 22;19(5):e0303448. doi: 10.1371/journal.pone.0303448. eColl PMID 38776307

Идентификаторы

NCT: NCT05740514 · 15516

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗