Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Shanghai
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Shanghai、Shanghai、中国、200025
- 募集
- Shanghai Jiao Tong University School of Medicine
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主任研究者:
- Guang Ning, MD,PhD
-
コンタクト:
- Guang Ning, MD,PhD
- 電話番号:665340 86-21-64370045
- メール:guangning@medmail.com.cn
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Excess Weight Loss
時間枠:up to 10 years
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up to 10 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Remission rate of type 2 diabetes mellitus or control of glycemia
時間枠:up to 10 years
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up to 10 years
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Waist circumference
時間枠:up to 10 years
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up to 10 years
|
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Hip circumference
時間枠:up to 10 years
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up to 10 years
|
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Fat percent determined by Inbody 720
時間枠:up to 10 years
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up to 10 years
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Assessment of insulin resistance
時間枠:up to 10 years
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up to 10 years
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Abdominal fat deposition
時間枠:up to 10 years
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up to 10 years
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Apnea hypopnea index by polysomnography
時間枠:up to 10 years
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up to 10 years
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Appetite assessed by Three-factor eating questionnaire (TFEQ)
時間枠:up to 10 years
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up to 10 years
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Gut microbiome
時間枠:up to 10 years
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up to 10 years
|
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Concentration of blood metabolites
時間枠:up to 10 years
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up to 10 years
|
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Appetite signal in brain determined by fMRI
時間枠:up to 10 years
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up to 10 years
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協力者と研究者
捜査官
- 主任研究者:Guang Ning, MD,PHD、Shanghai Jiao Tong University School of Medicine
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。