- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02653430
Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Prevalence of obesity has been increasing rapidly worldwide. Overweight and obesity prevalence surged to 35.1% according to China Noncommunicable Disease Surveillance 2010. An estimated 44% of the burden for diabetes has been attributed to these weight problems, as well as 23% and 7-41% of the burdens for ischaemic heart disease and specific cancers. So now, obesity is a very serious disease, and it is not easy to lose weight or maintain proper weight.
With the failure of non-surgical strategies, bariatric surgery has emerged as the most effective therapeutic option for the treatment of severe obesity. From the beginning, there are a lot of types of operation which have been created and then been abandoned. Now, the most common is Roux-en-Y gastric bypass, sleeve gastrectomy (SG), gastric banding, and biliopancreatic diversion. In recent years, the international status of SG surgery gradually went up. Since 2013, SG has been recommended as the preferred option of bariatric surgery by the American Weight Loss Society. However, the underlying mechanism of SG procedure is not fully clear.
In fact, clinical and translational studies over the last decade have shown that a number of gastrointestinal mechanisms, including changes in gut hormones, neural signalling, intestinal flora, bile acid and lipid metabolism can play a significant role in the effects of this procedure on energy homeostasis. This is a long-term follow-up and interventional study in individuals who have been diagnosed with moderate to severe obesity with or without diabetes. The purpose of this study is to determine the effects of SG on weight and blood sugar control and underlying mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI) ,adipose tissue expression chip and etc.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Shanghai
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Shanghai, Shanghai, China, 200025
- Recrutamento
- Shanghai Jiao Tong University School of Medicine
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Investigador principal:
- Guang Ning, MD,PhD
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Contato:
- Guang Ning, MD,PhD
- Número de telefone: 665340 86-21-64370045
- E-mail: guangning@medmail.com.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- BMI≥35kg/m2 with or without obesity complications
- BMI≥32kg/m2 with type 2 diabetes, high blood pressure, severe OSAHS, atherosclerotic plaque formation or other obesity complications
- Type 2 diabetes duration of ≤ 15 years, half of the lower limit of normal islet reserve function or more, C peptide ≥2.
Exclusion Criteria:
- had an operation for losing weight before
- serious hepatic or renal dysfunction
- mentally ill,serious tristimania,personality disturbance,disgnosia
- drug abuse or alcool abuse
- ulcer or tumor history or other high risks for surgery or serious gastrointestinal disease
- can not be follow-up,refuse to change the life-style
- type 1 diabetes mellitus
- self-care disable or no familial care
- obesity caused by drugs
- secondary obesity, such as monogenic obesity, obesity-related genetic syndrome, cushing syndrome and etc.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Bariatric Surgery
Sleeve Gastrectomy
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After complete exams such as EKG,UCG,spirometry and other basic exams,estimate the condition of patient whether he(she) can tolerate a surgical operation.Then we operate the"Sleeve gastrectomy laparoscopically" by a group of experienced surgeons.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Excess Weight Loss
Prazo: up to 10 years
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up to 10 years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Remission rate of type 2 diabetes mellitus or control of glycemia
Prazo: up to 10 years
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up to 10 years
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Waist circumference
Prazo: up to 10 years
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up to 10 years
|
|
Hip circumference
Prazo: up to 10 years
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up to 10 years
|
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Fat percent determined by Inbody 720
Prazo: up to 10 years
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up to 10 years
|
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Assessment of insulin resistance
Prazo: up to 10 years
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up to 10 years
|
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Abdominal fat deposition
Prazo: up to 10 years
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up to 10 years
|
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Apnea hypopnea index by polysomnography
Prazo: up to 10 years
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up to 10 years
|
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Appetite assessed by Three-factor eating questionnaire (TFEQ)
Prazo: up to 10 years
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up to 10 years
|
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Gut microbiome
Prazo: up to 10 years
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up to 10 years
|
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Concentration of blood metabolites
Prazo: up to 10 years
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up to 10 years
|
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Appetite signal in brain determined by fMRI
Prazo: up to 10 years
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up to 10 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine
Publicações e links úteis
Publicações Gerais
- Hong J, Bo T, Xi L, Xu X, He N, Zhan Y, Li W, Liang P, Chen Y, Shi J, Li D, Yan F, Gu W, Wang W, Liu R, Wang J, Wang Z, Ning G. Reversal of Functional Brain Activity Related to Gut Microbiome and Hormones After VSG Surgery in Patients With Obesity. J Clin Endocrinol Metab. 2021 Aug 18;106(9):e3619-e3633. doi: 10.1210/clinem/dgab297.
- Chen Y, Chen L, Ye L, Jin J, Sun Y, Zhang L, Zhao S, Zhang Y, Wang W, Gu W, Hong J. Association of Metabolic Syndrome With Prevalence of Obstructive Sleep Apnea and Remission After Sleeve Gastrectomy. Front Physiol. 2021 Mar 31;12:650260. doi: 10.3389/fphys.2021.650260. eCollection 2021.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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 (Estimativa)
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
- CCEMD026
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