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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02653430
• Other study ID #: CCEMD026
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2015
• Last updated: April 25, 2016
• Start date: February 2012
• Est. completion date: December 2018

Study information

• Verified date: January 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Guang Ning, MD,PhD
• Phone: 86-21-64370045
• Email: guangning[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess Weight Loss		up to 10 years	No
Secondary	Remission rate of type 2 diabetes mellitus or control of glycemia		up to 10 years	No
Secondary	Waist circumference		up to 10 years	No
Secondary	Hip circumference		up to 10 years	No
Secondary	Fat percent determined by Inbody 720		up to 10 years	No
Secondary	Assessment of insulin resistance		up to 10 years	No
Secondary	Abdominal fat deposition		up to 10 years	No
Secondary	Apnea hypopnea index by polysomnography		up to 10 years	No
Secondary	Appetite assessed by Three-factor eating questionnaire (TFEQ)		up to 10 years	No
Secondary	Gut microbiome		up to 10 years	No
Secondary	Concentration of blood metabolites		up to 10 years	No
Secondary	Appetite signal in brain determined by fMRI		up to 10 years	No