Clinical trial NCT02653430: Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
Official title: Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Keywords: obesity
BMI
efficacy
bariatric surgery
gut flora
fMRI
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Excess Weight Loss
timeFrame: up to 10 years
Secondary outcomes:
measure: Remission rate of type 2 diabetes mellitus or control of glycemia
timeFrame: up to 10 years
measure: Waist circumference
timeFrame: up to 10 years
measure: Hip circumference
timeFrame: up to 10 years
measure: Fat percent determined by Inbody 720
timeFrame: up to 10 years
measure: Assessment of insulin resistance
timeFrame: up to 10 years
measure: Abdominal fat deposition
timeFrame: up to 10 years
measure: Apnea hypopnea index by polysomnography
timeFrame: up to 10 years
measure: Appetite assessed by Three-factor eating questionnaire (TFEQ)
timeFrame: up to 10 years
measure: Gut microbiome
timeFrame: up to 10 years
measure: Concentration of blood metabolites
timeFrame: up to 10 years
measure: Appetite signal in brain determined by fMRI
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Guang Ning, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.