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

Shanghai Jiao Tong University School of Medicine

Status

Unknown

Conditions

Morbid Obesity

Treatments

Procedure: Sleeve gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02653430

CCEMD026

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

16 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.