Morbid ObesityNCT02653430
Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
A study testing Sleeve gastrectomy in people with Morbid Obesity, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Guang Ning, MD,PhD, 86-21-64370045 ext. 665340, guangning@medmail.com.cn
Guang Ning, MD,PhD
About this study
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.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Sleeve gastrectomy
- Keywords
- obesity, BMI, efficacy, bariatric surgery, gut flora, fMRI
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | Sleeve Gastrectomy Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess Weight Loss
Measured: up to 10 years
Secondary outcomes (11)
Remission rate of type 2 diabetes mellitus or control of glycemia
Measured: up to 10 years
Waist circumference
Measured: up to 10 years
Hip circumference
Measured: up to 10 years
Fat percent determined by Inbody 720
Measured: up to 10 years
Assessment of insulin resistance
Measured: up to 10 years
Abdominal fat deposition
Measured: up to 10 years
Apnea hypopnea index by polysomnography
Measured: up to 10 years
Appetite assessed by Three-factor eating questionnaire (TFEQ)
Measured: up to 10 years
Gut microbiome
Measured: up to 10 years
Concentration of blood metabolites
Measured: up to 10 years
Appetite signal in brain determined by fMRI
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startFeb 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD,PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653430
- Sponsor's protocol ID
- CCEMD026
- Status last verified
- Jan 2016
- First submitted
- 30 Dec 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33950216Chen 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.
PubMed 33868016
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism Study of Bariatric Surgery to Treat Moderate to Severe Obesity in Han Chinese Population
- ClinicalTrials.gov ID
- NCT02653430
- Acronym / sponsor ID
- CCEMD026
- Conditions
- Morbid Obesity
- Keywords
- obesity, BMI, efficacy, bariatric surgery, gut flora, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Procedure: Sleeve gastrectomySleeve Gastrectomy |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomyAfter 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. | Procedure or surgery | Bariatric Surgery |
Primary outcome
Excess Weight Loss
Time frame: up to 10 years
11 secondary outcomes
Remission rate of type 2 diabetes mellitus or control of glycemia
Time frame: up to 10 years
Waist circumference
Time frame: up to 10 years
Hip circumference
Time frame: up to 10 years
Fat percent determined by Inbody 720
Time frame: up to 10 years
Assessment of insulin resistance
Time frame: up to 10 years
Abdominal fat deposition
Time frame: up to 10 years
Apnea hypopnea index by polysomnography
Time frame: up to 10 years
Appetite assessed by Three-factor eating questionnaire (TFEQ)
Time frame: up to 10 years
Gut microbiome
Time frame: up to 10 years
Concentration of blood metabolites
Time frame: up to 10 years
Appetite signal in brain determined by fMRI
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Derived from this study: PubMed 33950216Hong 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.
- Derived from this study: PubMed 33868016Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Ning, MD,PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy in people with Morbid Obesity, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guang Ning, MD,PhD (86-21-64370045 ext. 665340, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess Weight Loss (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653430, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.