- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02653430
Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Shanghai
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Shanghai, Shanghai, 중국, 200025
- 모병
- Shanghai Jiao Tong University School of Medicine
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수석 연구원:
- Guang Ning, MD,PhD
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연락하다:
- Guang Ning, MD,PhD
- 전화번호: 665340 86-21-64370045
- 이메일: guangning@medmail.com.cn
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Excess Weight Loss
기간: up to 10 years
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up to 10 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Remission rate of type 2 diabetes mellitus or control of glycemia
기간: up to 10 years
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up to 10 years
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Waist circumference
기간: up to 10 years
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up to 10 years
|
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Hip circumference
기간: up to 10 years
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up to 10 years
|
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Fat percent determined by Inbody 720
기간: up to 10 years
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up to 10 years
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Assessment of insulin resistance
기간: up to 10 years
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up to 10 years
|
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Abdominal fat deposition
기간: up to 10 years
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up to 10 years
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Apnea hypopnea index by polysomnography
기간: up to 10 years
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up to 10 years
|
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Appetite assessed by Three-factor eating questionnaire (TFEQ)
기간: up to 10 years
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up to 10 years
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Gut microbiome
기간: up to 10 years
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up to 10 years
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Concentration of blood metabolites
기간: up to 10 years
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up to 10 years
|
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Appetite signal in brain determined by fMRI
기간: up to 10 years
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up to 10 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .