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- Ensaio Clínico NCT04098549
The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes (RaSlo-19)
24 de junho de 2020 atualizado por: Steno Diabetes Center Copenhagen
In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential.
Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production.
Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response.
However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings.
Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes.
In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits.
On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon.
The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase.
This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose.
We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
10
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
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-
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Gentofte, Dinamarca, 2820
- Steno Diabetes Center Copenhagen
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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
18 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age 18-70 years
- Duration of Type 1 Diabetes ≥ 3 years
- Insulin pump use > 6 months
Exclusion Criteria:
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
- Use of medications that are known to cause QT interval prolongation
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Females who have different basal insulin pattern depending on their menstrual cycle
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Rapid-Slow
This arm will begin with intervention "rapid" (rapid rate of fall in plasma glucose) for the first study visit and proceed to intervention "slow" (slow rate of fall in plasma glucose) for the second study visit.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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Experimental: Slow-Rapid
This arm will begin with intervention "slow" (slow rate of fall in plasma glucose) for the first study visit and proceed to intervention "rapid" (rapid rate of fall in plasma glucose) for the second study visit.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level)
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Total area under the glucose curve (AUC)
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Peak plasma glucose
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Incremental plasma glucose peak
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Time-to-peak plasma glucose
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Plasma glucose level
Prazo: 120 minutes after glucagon administration
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120 minutes after glucagon administration
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Duration of plasma glucose above 4.0 mmol/l
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of plasma glucose above baseline
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Number of subjects who, after reaching a plasma glucose value > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-10 mmol/l
Prazo: throughout phase 4 (until 120 minutes after glucagon administration)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Number of subjects who, after reaching a PG > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-7.8 mmol/l
Prazo: throughout phase 4 (until 120 minutes after glucagon administration)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-10 mmol/l
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Change in insulin levels (measured as area under the curve)
Prazo: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in insulin levels (measured as peak change)
Prazo: from baseline to 120 minutes after glucagon administration
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from baseline to 120 minutes after glucagon administration
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Change in glucagon levels (measured as area under the curve)
Prazo: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in glucagon levels (measured as peak change)
Prazo: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Average changes in Edinburgh Hypoglycemia Scale
Prazo: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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Average change in visual analogue scale score for nausea, headache, stomach ache and palpitations
Prazo: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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Number of subjects experiencing vomiting
Prazo: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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)
12 de setembro de 2019
Conclusão Primária (Real)
15 de janeiro de 2020
Conclusão do estudo (Real)
15 de janeiro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
11 de setembro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de setembro de 2019
Primeira postagem (Real)
23 de setembro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 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
- H-19034585
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
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
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