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

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ClinicalTrials.gov Identifier: NCT02653430
Recruitment Status : Unknown
Verified January 2016 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : January 12, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Sleeve gastrectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
Study Start Date : February 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Excess Weight Loss [ Time Frame: up to 10 years ]

Secondary Outcome Measures :
  1. Remission rate of type 2 diabetes mellitus or control of glycemia [ Time Frame: up to 10 years ]
  2. Waist circumference [ Time Frame: up to 10 years ]
  3. Hip circumference [ Time Frame: up to 10 years ]
  4. Fat percent determined by Inbody 720 [ Time Frame: up to 10 years ]
  5. Assessment of insulin resistance [ Time Frame: up to 10 years ]
  6. Abdominal fat deposition [ Time Frame: up to 10 years ]
  7. Apnea hypopnea index by polysomnography [ Time Frame: up to 10 years ]
  8. Appetite assessed by Three-factor eating questionnaire (TFEQ) [ Time Frame: up to 10 years ]
  9. Gut microbiome [ Time Frame: up to 10 years ]
  10. Concentration of blood metabolites [ Time Frame: up to 10 years ]
  11. Appetite signal in brain determined by fMRI [ Time Frame: up to 10 years ]


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653430


Contacts
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Contact: Guang Ning, MD,PhD 86-21-64370045 ext 665340 guangning@medmail.com.cn

Locations
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China, Shanghai
Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, MD,PhD    86-21-64370045 ext 665340    guangning@medmail.com.cn   
Principal Investigator: Guang Ning, MD,PhD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Guang Ning, MD,PhD Shanghai Jiao Tong University School of Medicine

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Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02653430     History of Changes
Other Study ID Numbers: CCEMD026
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: January 2016
Keywords provided by Guang Ning, Shanghai Jiao Tong University School of Medicine:
obesity
BMI
efficacy
bariatric surgery
gut flora
fMRI
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms