ObesityNCT05127213
Effects of Intragastric Balloon Surgery and Sleeve Gastrectomy on Brain Function
A study testing Intragastric balloon system and Sleeve gastrectomy in people with Obesity, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This is a prospective, single-center, randomized, open-label, parallel-controlled clinical trial to compare the changes in brain function after intragastric balloon and sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intragastric balloon system and Sleeve gastrectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Dec 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ age ≤ 65, regardless of gender;
- BMI ≥ 27.5kg/m2 and ≤ 40kg / m2;
- Those who have tried other weight loss methods in the past but are not satisfied with the results;
- Willingness to comply with the study requirements, including willingness to avoid the use of drugs or other substances for weight loss during the follow-up study;
- Right handed, avoid using antibiotics and probiotics within 3 month before enrollment;
- Be able to take proton pump inhibitors and antiemetics according to the regulations of the researcher;
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- It can walk completely independently without any serious chronic orthopedic diseases;
- Be willing to avoid the use of non-steroidal anti-inflammatory drugs during the study, including aspirin, diclofenac, ibuprofen, naproxen or other known gastric irritants;
- Willing to accept gastroscopy;
- Voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Patients with previous or current diagnosis of ketoacidosis;
- Symptomatic congestive heart failure, arrhythmia or unstable coronary artery disease;
- Currently suffering from respiratory diseases such as chronic obstructive pulmonary disease (COPD), pneumonia or lung cancer;
- Have undergone weight loss surgery before enrollment in the study, or may have undergone weight loss surgery during the study;
- Before the study, he used intragastric medical devices to lose weight;
- Had acute or chronic pancreatitis within 12 months before enrollment;
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- Previous or current history of small bowel obstruction
- Obesity caused by genetic endocrine reasons (test results of cortical hormone and thyroid hormone, clinically significant abnormalities determined by the researcher) and not fully controlled by drugs;
- Esophageal, gastric or duodenal diseases (including hiatal hernia (≥ 2cm), paraesophageal hernia, polyps, acute erosive gastritis, cancer, varices, diverticulum, gastroparesis, ulcer, stenosis, achalasia of cardia complicated with esophagitis, etc.);
- Systemic corticosteroid anticoagulants (such as warfarin, dabigatran or antiplatelet drugs), immunosuppressive drugs (such as imidazole thiopurine, cyclosporine), prescription or over-the-counter weight loss drugs, drugs known to cause significant weight gain or weight loss, such as anesthetics, opioids or diazepines), insulin Antiepileptic drugs (such as clonazepam and phenytoin sodium), antiarrhythmic drugs (such as amiodarone); Other drugs that may cause weight change include: drugs that can significantly increase weight (such as glucocorticoids, insulin secretagogues, thiazolidinediones, atypical antipsychotics, sodium valproate, lamotrigine, antidepressants), and drugs that can significantly reduce weight (such as glucagon like peptide-1 receptor agonists α- Glucosidase inhibitor, zonisamide, topiramate, fluoxetine, bupropion, etc.);
- Night eating syndrome or bulimia;
- Unwilling to avoid any reconstruction and / or plastic surgery that may affect body weight during the study, such as mastoplasty and liposuction;
- Patients with inflammatory bowel disease (such as Crohn's disease and ulcerative colitis);
- Previous history of malignant tumor;
- Women of childbearing age whose pregnancy test is not negative before examination, lactating women, or who plan to conceive within half a year;
- Past or current drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Shaihong Zhu, M.D., +86 15974267868, zshcsu@163.com
Shaihong Zhu, M.D.
About this study
Official title: Comparison of the Effects of Brain Function Changes on Body Weight After Intragastric Balloon Surgery and Sleeve Gastric Surgery
This is a prospective, single-center, randomized, open-label, parallel-controlled clinical trial to compare the changes in brain function after intragastric balloon and sleeve gastrectomy.
Read the detailed description
To compare the changes in brain function in obese patients after intragastric balloon and sleeve gastrectomy. This clinical trial is a prospective, single-center, randomized, open-label, parallel-controlled study. One group uses intragastric balloon system developed by Changzhou Zhishan Medical Technology Co., Ltd, and the other groups underwent sleeve gastric surgery. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. They are divided into different groups according to their own wishes. To evaluate the primary outcome measures and secondary outcome measures and to observe the changes in brain function. Finally, investigators used functional MRI, questionnaire, and laboratory examination to evaluate the weight loss effect and appetite change through the comparison of the data obtained from the different groups during the treatment.
- Conditions
- Obesity
- Being tested
- Intragastric balloon system, Sleeve gastrectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragastric balloon systemProcedure or surgery
Intragastric balloon system (PA450) developed and produced by Changzhou Zhishan Medical Technology Co., Ltd. It is a swallowable capsule intragastric balloon.The degradable material on the intragastric balloon can be degraded naturally, and the balloon is naturally discharged from the body through the gastrointestinal tract
Sleeve gastrectomyProcedure or surgery
Sleeve gastrectomy is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Intragastric balloon system group | Experimental | Operation way: intragastric balloon system
Using the intragastric balloon system to treat obesity. Receives: Procedure: Intragastric balloon system |
| Sleeve gastrectomy group | Experimental | Operation way: sleeve gastrectomy
Using the sleeve gastrectomy to treat obesity. Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean overall weight loss response rate
(Weight loss / total weight before treatment × 100%≥5%) number of subjects / total number of subjects × 100%
Measured: 16 weeks after operation
Secondary outcomes (7)
Mean total weight loss percentage of subjects（%TWL）
Weight loss / total weight before treatment × 100%
Measured: The 16th, 24th and 32nd weeks after operation
Weight loss maintenance
Weight loss and maintenance of subjects
Measured: The 16th, 24th and 32nd weeks after operation
Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire
Change in obesity-specific health-related quality of life as measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire total score from baseline to 32 weeks Minimum 0 Maximum 100 Higher score means better
Measured: The 16th, 24th and 32nd weeks after operation
Questionnaire
Evaluation of postoperative appetite related questionnaire（the Hospital Anxiety and Depression Scale, the Three-Factor Eating Questionnaire R21, the Yale Food Addiction Scale 2.0）
Measured: Preoperative and postoperative weeks 16, 24 and 32
Gastrointestinal hormone
Changes of gastrointestinal hormone（ghrelin，leptin，cholecystokinin，adiponectin） levels after operation
Measured: Preoperative and postoperative weeks 16, 24 and 32
Brain function
Brain functional magnetic resonance imaging
Measured: Preoperative and postoperative weeks 16, 24 and 32
Correlation of fecal microbial profile with obesity
Analysis of fecal microbial profile using 16s rRNA sequencing
Measured: Preoperative and postoperative weeks 16, 24 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaihong Zhu, M.D., Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127213
- Sponsor's protocol ID
- XY3-IGBWLG001
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Brain Function Changes on Body Weight After Intragastric Balloon Surgery and Sleeve Gastric Surgery
- ClinicalTrials.gov ID
- NCT05127213
- Acronym / sponsor ID
- XY3-IGBWLG001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 Nov 2021 (actual)
- 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 prospective, single-center, randomized, open-label, parallel-controlled clinical trial to compare the changes in brain function after intragastric balloon and sleeve gastrectomy.
Detailed description
To compare the changes in brain function in obese patients after intragastric balloon and sleeve gastrectomy. This clinical trial is a prospective, single-center, randomized, open-label, parallel-controlled study. One group uses intragastric balloon system developed by Changzhou Zhishan Medical Technology Co., Ltd, and the other groups underwent sleeve gastric surgery. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. They are divided into different groups according to their own wishes. To evaluate the primary outcome measures and secondary outcome measures and to observe the changes in brain function. Finally, investigators used functional MRI, questionnaire, and laboratory examination to evaluate the weight loss effect and appetite change through the comparison of the data obtained from the different groups during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intragastric balloon system group | Experimental | Procedure: Intragastric balloon systemOperation way: intragastric balloon system Using the intragastric balloon system to treat obesity. |
| Sleeve gastrectomy group | Experimental | Procedure: Sleeve gastrectomyOperation way: sleeve gastrectomy Using the sleeve gastrectomy to treat obesity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 ≤ age ≤ 65, regardless of gender;
- BMI ≥ 27.5kg/m2 and ≤ 40kg / m2;
- Those who have tried other weight loss methods in the past but are not satisfied with the results;
- Willingness to comply with the study requirements, including willingness to avoid the use of drugs or other substances for weight loss during the follow-up study;
- Right handed, avoid using antibiotics and probiotics within 3 month before enrollment;
Key exclusion criteria (16 listed)
- Patients with previous or current diagnosis of ketoacidosis;
- Symptomatic congestive heart failure, arrhythmia or unstable coronary artery disease;
- Currently suffering from respiratory diseases such as chronic obstructive pulmonary disease (COPD), pneumonia or lung cancer;
- Have undergone weight loss surgery before enrollment in the study, or may have undergone weight loss surgery during the study;
- Before the study, he used intragastric medical devices to lose weight;
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 |
|---|---|---|
| Intragastric balloon systemIntragastric balloon system (PA450) developed and produced by Changzhou Zhishan Medical Technology Co., Ltd. It is a swallowable capsule intragastric balloon.The degradable material on the intragastric balloon can be degraded naturally, and the balloon is naturally discharged from the body through the gastrointestinal tract | Procedure or surgery | Intragastric balloon system group |
| Sleeve gastrectomySleeve gastrectomy is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss. | Procedure or surgery | Sleeve gastrectomy group |
Primary outcome
Mean overall weight loss response rate
Time frame: 16 weeks after operation
(Weight loss / total weight before treatment × 100%≥5%) number of subjects / total number of subjects × 100%
7 secondary outcomes
Mean total weight loss percentage of subjects（%TWL）
Time frame: The 16th, 24th and 32nd weeks after operation
Weight loss maintenance
Time frame: The 16th, 24th and 32nd weeks after operation
Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire
Time frame: The 16th, 24th and 32nd weeks after operation
Questionnaire
Time frame: Preoperative and postoperative weeks 16, 24 and 32
Gastrointestinal hormone
Time frame: Preoperative and postoperative weeks 16, 24 and 32
Brain function
Time frame: Preoperative and postoperative weeks 16, 24 and 32
Correlation of fecal microbial profile with obesity
Time frame: Preoperative and postoperative weeks 16, 24 and 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
Shaihong Zhu, M.D. principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intragastric balloon system and Sleeve gastrectomy in people with Obesity, run by The Third Xiangya Hospital of Central South University 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 10 inclusion and 16 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 19 Nov 2021. 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 Shaihong Zhu, M.D. (+86 15974267868, zshcsu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean overall weight loss response rate (time frame: 16 weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2021.