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- Ensaio Clínico NCT05097339
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
Visão geral do estudo
Status
Condições
Descrição detalhada
Compare values and trends of different biomarkers (glucose, lactate and beta-hydroxybutyrate) before, during and after morning aerobic and symptom limited maximal exercise (cycling) to predict glycemic fluctuations (hypo- and hyperglycemic events) during and after exercise in order to create treatment algorithms to prevent these events.
Endpoint:
• Evaluate values and trends of glucose, lactate and beta-hydroxybutyrate before, during and after morning exercise in venous blood.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Antwerp
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Edegem, Antwerp, Bélgica, 2650
- Antwerp University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Male adults (18-40 years old) with T1D, diagnosed since > 1 year
- Using a CGM (Dexcom G5) or willing to wear a CGM (Dexcom G5) for the duration of the study.
The CGM must be applied >48h before the exercise test
- Participants are on intensified insulin therapy (MDI) or insulin pump therapy (CSII)
- 6% ≤ HbA1c ≤ 8%
- Having a self-reported moderate activity level on the iPAQ (Internationally Physical Activity Questionnaire).
- C-peptide <0.2 nmol/l
- The Physical Activity Coefficient has not changed in the 2 months prior to the first Exercise Test.
- 20kg/m2 < BMI < 25kg/m2
Exclusion Criteria:
- Recently diagnosed T1D (< 12mo)
- Participants not on MDI or CSII
- Musculoskeletal disorder that affects cycling or is a contra-indication for vigorous physical activity
- Cardiorespiratory disease or ECG abnormality that is a contra-indication for vigorous physical activity
- Having an acute illness (e.g. influenza) that interferes with glucose metabolism
- Having a metabolic disorder (different from diabetes) or takes drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
- Presence of concomitant pathology such as heart failure, liver failure, kidney failure defined as eGFR <45mL/min
- Patient not able or willing to sign the patient informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Outro
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Patients with type 1 diabetes
Patients with type 1 diabetes perform a morning Symptom Limited Maximal Exercise Test (CPET) or a 60-minute morning Aerobic Test (AEX) at 60% VO2peak
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in glucose concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Prazo: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
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Glucose levels in mg/dL during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
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Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
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Change in lactate concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Prazo: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
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Lactate levels in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
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Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
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Change in ketone concentration during and after morning Aerobic and Symptom Limited Maximal Exercise Test
Prazo: Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
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Ketone levels (Beta-hydroxybutyrate) in mmol/mol during and after morning Aerobic (60 minutes at 60% of VO2 max) and Symptom Limited Maximal Exercise Test (AEX & CPET), measured in 21 patients through YSI (YSI Life Sciences, Yellow Springs, OH)
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Blood sampling was done before the exercise, every 3 minutes for CPET and every 5 minutes for AEX during the exercise and every 15 minutes during the first hour of recovery and every 20 minutes during the rest of the 6-hour follow-up.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christophe De Block, MD, PhD, University Hospital, Antwerp
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- ACTION1
Plano para dados de participantes individuais (IPD)
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