Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring obesity, BMI, efficacy, bariatric surgery, gut flora, fMRI
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.
Sites / Locations
- Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bariatric Surgery
Arm Description
Sleeve Gastrectomy
Outcomes
Primary Outcome Measures
Excess Weight Loss
Secondary Outcome Measures
Remission rate of type 2 diabetes mellitus or control of glycemia
Waist circumference
Hip circumference
Fat percent determined by Inbody 720
Assessment of insulin resistance
Abdominal fat deposition
Apnea hypopnea index by polysomnography
Appetite assessed by Three-factor eating questionnaire (TFEQ)
Gut microbiome
Concentration of blood metabolites
Appetite signal in brain determined by fMRI
Full Information
NCT ID
NCT02653430
First Posted
December 30, 2015
Last Updated
April 25, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02653430
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
obesity, BMI, efficacy, bariatric surgery, gut flora, fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bariatric Surgery
Arm Type
Experimental
Arm Description
Sleeve Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Excess Weight Loss
Time Frame
up to 10 years
Secondary Outcome Measure Information:
Title
Remission rate of type 2 diabetes mellitus or control of glycemia
Time Frame
up to 10 years
Title
Waist circumference
Time Frame
up to 10 years
Title
Hip circumference
Time Frame
up to 10 years
Title
Fat percent determined by Inbody 720
Time Frame
up to 10 years
Title
Assessment of insulin resistance
Time Frame
up to 10 years
Title
Abdominal fat deposition
Time Frame
up to 10 years
Title
Apnea hypopnea index by polysomnography
Time Frame
up to 10 years
Title
Appetite assessed by Three-factor eating questionnaire (TFEQ)
Time Frame
up to 10 years
Title
Gut microbiome
Time Frame
up to 10 years
Title
Concentration of blood metabolites
Time Frame
up to 10 years
Title
Appetite signal in brain determined by fMRI
Time Frame
up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang Ning, MD,PhD
Phone
86-21-64370045
Ext
665340
Email
guangning@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Ning, MD,PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang Ning, MD,PhD
Phone
86-21-64370045
Ext
665340
Email
guangning@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Guang Ning, MD,PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33950216
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.
Results Reference
derived
PubMed Identifier
33868016
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.
Results Reference
derived
Learn more about this trial
Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
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