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O estudo clínico NCT04263168 para Diabetes mellitus, Candidato à cirurgia bariátrica está retirado. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Centro Médico Chaim ShebaGlycemic Index Variations In the Early Period Following Bariatric Surgery Microbioma
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT04263168 é um estudo intervencionista para Diabetes mellitus, Candidato à cirurgia bariátrica. Seu status atual é: retirado. O estudo começou em 1 de março de 2020 e pretende incluir N/A participantes. Coordenado por o Centro Médico Chaim Sheba e deve ser concluído em 1 de agosto de 2022. Essas informações foram atualizadas no ClinicalTrials.gov em 11 de outubro de 2021.
Resumo
The diverse community of gut microbes commonly referred to as the 'gut microbiome', is increasingly suggested to play significant roles in health and disease, and to affect even distant non-GI organs by metabolite signaling. Type 2 diabetes mellitus (T2DM) patients feature a distinct gut microbiome signature4, while modulating the gut microbiome by either antibiotics or fecal microbial transplantation (FMT) is sugges...Mostrar mais
Descrição detalhada
Type 2 diabetes mellitus (T2DM) is one of the most prevalent and deadly conditions in the 21st century. T2DM is characterized by obesity and insulin resistance that leads to chronic hyperglycemia, which even with best medical care is often uncontrolled, resulting in life-threatening micro- and macrovascular complications.
The gut microbiota (i.e. the microbial population inhabiting the gut) has been extensively link...
Mostrar maisTítulo oficial
Glycemic Index Variations In the Early Period Following Bariatric Surgery
Condições médicas
Diabetes mellitusCandidato à cirurgia bariátricaOutros IDs do estudo
- 6397-19-SMC
Número NCT
Data de início (real)
2020-03-01
Última atualização postada
2021-10-11
Data de conclusão (estimada)
2022-08-01
Tipo de estudo
Intervencionista
FASE
N/A
Status
Retirado
Propósito principal
Ciência básica
Alocação do design
Não randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalBariatric Surgery Candidates All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose moni...Mostrar mais | Continuous Glucose monitoring in the perioperative period All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose moni...Mostrar mais |
Comparador simuladoLaparoscopy Cholecystectomy All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose moni...Mostrar mais | Continuous Glucose monitoring in the perioperative period All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose moni...Mostrar mais |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Changes in intestinal microbiota composition prior and following bariatric surgery | Changes in intestinal microbiota composition following bariatric surgery measured with RNA sequencing | two weeks |
Changes in glycemic index prior and following bariatric surgery | Changes in glycemic index prior and following bariatric surgery measured with continues glucose monitoring system (FreeStyle Libre) | two weeks |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Adult Population (> 18 years old)
- Diabetic Patients (Type 2)
- Bariatric surgery candidates for two types of bariatric surgery, i.e. sleeve gastrectomy and Roux-en-Y gastric bypass
- Laparoscopic Cholecystectomy candidates
- Pregnant Women
- < 18 years old
Centro Médico Chaim Sheba74 estudos clínicos ativos para explorarWeizmann Institute of ScienceResponsável pelo estudo
Dr. Nir Horesh resident Department of Surgery and Transplant, Investigador principal, Principal Investigator, Sheba Medical Center
Sem dados de contato.
1 Locais do estudo em 1 países
Tel Aviv (Gosh Dan)
Sheba Medical Center, Ramat Gan, Tel Aviv (Gosh Dan), 52561, Israel