Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia
8 de junho de 2020 atualizado por: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required.
Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level.
In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise.
Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
37
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Quebec
-
Montreal, Quebec, Canadá
- Institut de recherches cliniques de Montreal
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
14 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Males and females ≥ 14 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Last (less than 3 months) HbA1c ≤ 10%.
- Patients using multiple daily injections with basal-bolus insulin regimen.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Full snack given before exercise
A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise
|
Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
|
|
Comparador Ativo: Distributed snack over exercise period
A snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
|
Participants will be admitted at IRCM at 14:00.
At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
During exercise, capillary glucose levels will be measured every 10 minutes.
At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour.
At 17:30, the participant will be discharged.
Full snack or Distributed snack
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
Prazo: This outcome will be measured over 120 minutes
|
This time frame corresponds to the exercise period and the 1 hour following it
|
This outcome will be measured over 120 minutes
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of time of sensor glucose levels spent between 4-10 mmol/L
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Decrease in glucose levels
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
Increase in glucose level
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise.
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
Number of participants with an exercise-induced hypoglycemia below 4 mmol/L
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Number of participants requiring an oral treatment for hypoglycemia
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Total number of hypoglycemia episodes requiring treatment
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Mean time (minutes) to the first hypoglycemic event
Prazo: This outcome will be measured for the exercise period only (60 minutes)
|
This outcome will be measured for the exercise period only (60 minutes)
|
|
|
Mean glucose levels
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Standard deviation of glucose levels
Prazo: This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Prazo: From the end of the exercise period to dinner time.
|
Dinner time will be up to the patient.
|
From the end of the exercise period to dinner time.
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Prazo: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Prazo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels between 4 and 10 mmol/L
Prazo: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Prazo: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient.
|
From the end of the exercise period to dinner time
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Prazo: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Prazo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels spent below 4 mmol/L
Prazo: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Prazo: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Prazo: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Prazo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Percentage of time of glucose levels spent above 10 mmol/L
Prazo: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Prazo: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Number of participants requiring treatment for hypoglycemia
Prazo: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Prazo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of participants requiring treatment for hypoglycemia
Prazo: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Prazo: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Number of hypoglycemic episodes requiring treatment
Prazo: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Prazo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Number of hypoglycemic episodes requiring treatment
Prazo: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
|
|
Mean glucose levels
Prazo: From the end of the exercise period to dinner time
|
Dinner time will be up to the patient
|
From the end of the exercise period to dinner time
|
|
Mean glucose levels
Prazo: From the end of the exercise period to midnight (7.5 hours)
|
From the end of the exercise period to midnight (7.5 hours)
|
|
|
Mean glucose levels
Prazo: From midnight to 6:00 next morning (6 hours)
|
From midnight to 6:00 next morning (6 hours)
|
|
|
Mean glucose levels
Prazo: From the end of the exercise period to 6:00 next morning (13.5 hours)
|
From the end of the exercise period to 6:00 next morning (13.5 hours)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de agosto de 2017
Conclusão Primária (Real)
2 de agosto de 2019
Conclusão do estudo (Real)
2 de agosto de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
6 de julho de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2017
Primeira postagem (Real)
11 de julho de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2020
Última verificação
1 de junho de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SNACK-1
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .