Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population

Study Overview
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Brief Summary
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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 sleeve gastrectomy on weight and blood sugar control and underlying mechanisms by metabolomics, metagenomics, functional magnetic resonance imaging (fMRI) ,adipose tissue expression chip and etc.

Detailed Description
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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.

Official Title
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Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bariatric Surgery<br>Sleeve Gastrectomy | Procedure: Sleeve gastrectomy<br>* 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 theSleeve gastrectomy laparoscopically by a group of experienced surgeons.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess Weight Loss |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate of type 2 diabetes mellitus or control of glycemia |  | up to 10 years | 
| Waist circumference |  | up to 10 years | 
| Hip circumference |  | up to 10 years | 
| Fat percent determined by Inbody 720 |  | up to 10 years | 
| Assessment of insulin resistance |  | up to 10 years | 
| Abdominal fat deposition |  | up to 10 years | 
| Apnea hypopnea index by polysomnography |  | up to 10 years | 
| Appetite assessed by Three-factor eating questionnaire (TFEQ) |  | up to 10 years | 
| Gut microbiome |  | up to 10 years | 
| Concentration of blood metabolites |  | up to 10 years | 
| Appetite signal in brain determined by fMRI |  | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, BMI, efficacy, bariatric surgery, gut flora, fMRI