The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial (VIGOR)
Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).
Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Alberta
-
Calgary, Alberta, Canadá, T2N 1N4
- University Of Calgary
-
Edmonton, Alberta, Canadá, T6G 2R3
- University of Alberta
-
-
Manitoba
-
WInnipeg, Manitoba, Canadá, R3E 3P4
- Manitoba Institute of Child Health
-
-
Ontario
-
Hamilton, Ontario, Canadá, L8S 4L8
- McMaster University
-
Ottawa, Ontario, Canadá, K1N 6N5
- University of Ottawa
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age: 15-45 years old
- Have lived with type 1 diabetes for at least 2 years
- HbA1c <9.9%
- Currently physically inactive (<150 minutes of self-reported structured physical activity per week)
- Undergone a resting ECG to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise
Exclusion Criteria:
- Have frequent and unpredictable hypoglycaemia
- Had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment
- Are currently participating in structured activity or sport-related activities
- Are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding
- Have conditions that would render physical activity contraindicated including: uncontrolled hypertension (BP>150mmHg systolic or >95mmHg diastolic in a sitting position); severe peripheral neuropathy; history of cardiovascular disease
- Have a cognitive deficit resulting in an inability to provide informed consent
- Currently taking beta blockers
- Currently taking atypical antipsychotics or corticosteroids
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Moderate intensity exercise
150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness)
|
|
|
Comparador Ativo: Moderate + Vigorous Intensity Exercise
150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor.
Prazo: Measured at baseline, and 1, 8,16 and 52 weeks following randomization
|
Measured at baseline, and 1, 8,16 and 52 weeks following randomization
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome.
Prazo: Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
|
Measured at baseline, and 1, 8, 16 and 52 weeks following randomization
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B2012:136
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .