- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01935791
Investigating Brown Adipose Tissue Activation in Humans
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Outro: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
- Medicamento: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
- Outro: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
- Medicamento: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
- Medicamento: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
- Medicamento: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
- Medicamento: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
- Medicamento: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
- Medicamento: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
London, Reino Unido
- Imperial College London
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- aged >18 years
Exclusion Criteria:
- medical conditions
- recreational drug use
- participation in other trials within the preceding 2 months
- blood donation within 3 months of study participation
Plano de estudo
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 |
---|---|
Comparador Ativo: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine. Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of gelofusine without a cooling vest. |
Temperature
|
Experimental: Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon
Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine Visit 2 Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min without a cooling vest.
|
Hormone
|
Comparador Ativo: Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative
Visit 1. Participants underwent F-fluorodeoxyglucose (18F-FDG) positron emission tomography, computerised tomography-(PET)CT, whilst wearing a cooling vest and receiving an infusion of gelofusine. No brown adipose tissue (BAT) identified on visit 1, therefore no visit 2. |
Temperature
|
Experimental: Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control
Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. |
Hormone
|
Experimental: Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control
Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. |
Hormone
|
Experimental: Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon
Visit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 2 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees celsius. |
hormone
|
Experimental: Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control
Visit 1 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 3 - Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. |
hormone
|
Experimental: Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control
Visit 1- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 2 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 3- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. |
hormone
|
Experimental: Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon
Visit 1 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine. They were situated in an ambient temperature of 22-25 degrees Celsius. Visit 2- Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of gelofusine and wearing a cooling vest. Visit 3 Each participant had calorimetry testing and thermal imaging whilst receiving an infusion of Glucagon at a dose of 50ng/kg/min. They were situated in an ambient temperature of 22-25 degrees Celsius |
Hormone
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Brown Adipose Tissue Activation Following Glucagon or Saline Infusion
Prazo: 2hours
|
Period 1 Brown Adipose Tissue (BAT) activation measured using metabolic rate of glucose (MR[gluc]) during F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET-CT) for Cold PET-CT Vehicle vs Warm PET-CT Vehicle vs warm PET-CT Glucagon.
|
2hours
|
Increase in Energy Expenditure Following Glucagon or Saline Infusion
Prazo: 2hours
|
Period 2 Increase in energy expenditure measured using indirect calorimetry for Cold control vs Warm Control vs Warm Glucagon.
|
2hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Waljit Dhillo, Imperial College London
Publicações e links úteis
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
- 13HH0688
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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 .
Ensaios clínicos em Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle
-
University of UtahRescindidoAvaliação da Hipóxia de Tumores Cerebrais Primários e Metastáticos com Fluoromisonidazol, FDG e ÁguaCancer cerebralEstados Unidos
-
Ottawa Heart Institute Research CorporationConcluídoHipertensão arterial pulmonar | Hipertensão Pulmonar, Primária, 4 | Insuficiência Cardíaca Crônica do Lado Direito | Hipertensão Pulmonar, Primária, 2 | Hipertensão Pulmonar Primária, 3 | Cardiomiopatia Ventricular DireitoCanadá
-
Andrew D. Luster, M.D.,Ph.D.National Institute of Allergy and Infectious Diseases (NIAID)Concluído
-
Narendranath EpperlaEli Lilly and CompanyAinda não está recrutandoLinfoma de Zona MarginalEstados Unidos
-
Mayo ClinicNational Cancer Institute (NCI)SuspensoLinfoma de Hodgkin Recorrente | Linfoma de Hodgkin refratário | Linfoma não Hodgkin recorrente | Linfoma não Hodgkin refratário | Carcinoma de mama recorrente | Micose Fungóide Recorrente | Linfoma não Hodgkin cutâneo primário recorrente de células T | Câncer de Mama Estágio IV AJCC v6 e v7 | Adenocarcinoma... e outras condiçõesEstados Unidos
-
National Cancer Institute (NCI)Ativo, não recrutandoLinfoma Difuso de Grandes Células B | Linfoma de células B de alto grau com rearranjos MYC e BCL2 ou BCL6 | Linfoma Difuso de Grandes Células B, Sem Outra Especificação | Linfoma de duplo expressor | Linfoma Difuso de Grandes Células B EBV-Positivo, Sem Outra Especificação | Linfoma de Células... e outras condiçõesEstados Unidos
-
Mayo ClinicNational Cancer Institute (NCI)RecrutamentoLinfoma de Hodgkin Recorrente | Leucemia Mielomonocítica Crônica | Linfoma refratário | Linfoma Difuso Recorrente de Grandes Células B | Linfoma difuso de grandes células B refratário | Linfoma recorrente | Citopenia Clonal de Significado Indeterminado | Linfoma de células B de alto grau com rearranjos...Estados Unidos
-
National Cancer Institute (NCI)RecrutamentoLinfoma Mediastinal Primário de Grandes Células BEstados Unidos, Canadá, Austrália, Porto Rico
-
National Cancer Institute (NCI)NRG OncologyRecrutamentoAdenocarcinoma Colorretal Metastático | Câncer Colorretal Estágio IV AJCC v7Estados Unidos
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecrutamentoAdenocarcinoma Colorretal Metastático | Adenocarcinoma de cólon metastático | Adenocarcinoma retal metastático | Câncer de cólon estágio IV AJCC v8 | Câncer Colorretal Estágio IV AJCC v8 | Câncer Retal Estágio IV AJCC v8 | Carcinoma Colorretal Estável Microssatélite MetastáticoEstados Unidos