Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study (Chäs2)
25 de janeiro de 2018 atualizado por: University Hospital, Basel, Switzerland
Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study
Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.
16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.
Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.
The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
16
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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Basel, Suíça, CH-4031 Basel
- University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
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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
20 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
Male subjects
- non-smoking
- apparently healthy
- BMI >18 and ≤28 kg/m2 or BMI >30 and ≤35 kg/m2
- Age 20-65 years
- Subject is usually eating breakfast and lunch
- Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD) and sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner).
- Owner of a smartphone so they will be able to download and use the sleeping APP, Sleep cycle, prior to the study days.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
- Night shift workers
- Subjects suffering from sleep disturbances
- Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP >5mg/l)
- Impaired fasting glucose (fasting plasma glucose >5.5mmol/l)
- Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
- Kidney disease (creatinine > 1.5 mg/dl))
- Liver disease (transaminases >2x upper normal range)
- Heart disease
- Pulmonary disease
- Inflammatory disease
- History of carcinoma
- History of tuberculosis
- Alcohol consumption >40g/d
- Smoking
- Known allergy towards Kineret
- Known allergy to ingredients of the test meal
- Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
- Use of any investigational drug within 30 days prior to enrolment or within 5 half-lives of the investigational drug, whichever is longer
- Subject refusing or unable to give written informed consent
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: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
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Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
Outros nomes:
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
Outros nomes:
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Experimental: Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
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Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
Outros nomes:
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
Outros nomes:
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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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The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
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7 to 9 days (change between study day 1 and study day 2)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in postprandial glucose, insulin, C-peptide, glucagon-like Peptide (GLP)-1(active/total), GIP(active/total), PYY, IL-6, tumor necrosis factor (TNF)-alfa, sCRP and cortisol due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in heart rate due to any treatment (Anakinra vs. saline)
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Pulse watch
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7 to 9 days (change between study day 1 and study day 2)
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Change in insulin due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in C-peptide due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in GIP(active/total) due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in PYY due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in IL-6 due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in TNF-alfa due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in sCRP due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in cortisol due to any treatment (Anakinra vs. saline).
Prazo: 7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Marc Y Donath, MD, University Hospital, Basel, Switzerland
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
1 de agosto de 2016
Conclusão Primária (Real)
1 de abril de 2017
Conclusão do estudo (Real)
3 de abril de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
26 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de setembro de 2016
Primeira postagem (Estimativa)
27 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de janeiro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de janeiro de 2018
Última verificação
1 de janeiro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EKNZ BASEC 2016-00816
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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