Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
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|ClinicalTrials.gov Identifier: NCT02653430|
Recruitment Status : Unknown
Verified January 2016 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : January 12, 2016
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Procedure: Sleeve gastrectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Bariatric Surgery
Procedure: Sleeve gastrectomy
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.
- Excess Weight Loss [ Time Frame: up to 10 years ]
- Remission rate of type 2 diabetes mellitus or control of glycemia [ Time Frame: up to 10 years ]
- Waist circumference [ Time Frame: up to 10 years ]
- Hip circumference [ Time Frame: up to 10 years ]
- Fat percent determined by Inbody 720 [ Time Frame: up to 10 years ]
- Assessment of insulin resistance [ Time Frame: up to 10 years ]
- Abdominal fat deposition [ Time Frame: up to 10 years ]
- Apnea hypopnea index by polysomnography [ Time Frame: up to 10 years ]
- Appetite assessed by Three-factor eating questionnaire (TFEQ) [ Time Frame: up to 10 years ]
- Gut microbiome [ Time Frame: up to 10 years ]
- Concentration of blood metabolites [ Time Frame: up to 10 years ]
- Appetite signal in brain determined by fMRI [ Time Frame: up to 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653430
|Contact: Guang Ning, MD,PhD||86-21-64370045 ext firstname.lastname@example.org|
|Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Guang Ning, MD,PhD 86-21-64370045 ext 665340 email@example.com|
|Principal Investigator: Guang Ning, MD,PhD|
|Principal Investigator:||Guang Ning, MD,PhD||Shanghai Jiao Tong University School of Medicine|