- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02653430
Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Guang Ning, MD,PhD
- Numero di telefono: 665340 86-21-64370045
- Email: guangning@medmail.com.cn
Luoghi di studio
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Shanghai
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Shanghai, Shanghai, Cina, 200025
- Reclutamento
- Shanghai Jiao Tong University School of Medicine
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Investigatore principale:
- Guang Ning, MD,PhD
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Contatto:
- Guang Ning, MD,PhD
- Numero di telefono: 665340 86-21-64370045
- Email: guangning@medmail.com.cn
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Excess Weight Loss
Lasso di tempo: up to 10 years
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up to 10 years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Remission rate of type 2 diabetes mellitus or control of glycemia
Lasso di tempo: up to 10 years
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up to 10 years
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Waist circumference
Lasso di tempo: up to 10 years
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up to 10 years
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Hip circumference
Lasso di tempo: up to 10 years
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up to 10 years
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Fat percent determined by Inbody 720
Lasso di tempo: up to 10 years
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up to 10 years
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Assessment of insulin resistance
Lasso di tempo: up to 10 years
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up to 10 years
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Abdominal fat deposition
Lasso di tempo: up to 10 years
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up to 10 years
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Apnea hypopnea index by polysomnography
Lasso di tempo: up to 10 years
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up to 10 years
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Appetite assessed by Three-factor eating questionnaire (TFEQ)
Lasso di tempo: up to 10 years
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up to 10 years
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Gut microbiome
Lasso di tempo: up to 10 years
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up to 10 years
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Concentration of blood metabolites
Lasso di tempo: up to 10 years
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up to 10 years
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Appetite signal in brain determined by fMRI
Lasso di tempo: up to 10 years
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up to 10 years
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CCEMD026
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sleeve gastrectomy
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