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

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.

Study Overview

• Status: Unknown
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Sleeve gastrectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guang Ning, MD,PhD; Phone Number: 665340 86-21-64370045; Email: guangning@medmail.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Shanghai Jiao Tong University School of Medicine
      • Principal Investigator: Guang Ning, MD,PhD
      • Contact: Guang Ning, MD,PhD; Phone Number: 665340 86-21-64370045; Email: guangning@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bariatric Surgery; Sleeve Gastrectomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Excess Weight Loss	up to 10 years

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Guang Ning, MD,PHD, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: January 9, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery; fMRI; efficacy; BMI; gut flora
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CCEMD026