Effects of Intragastric Balloon Surgery and Sleeve Gastrectomy on Brain Function
NCT ID: NCT05127213
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-11-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intragastric balloon system group
Operation way: intragastric balloon system
Using the intragastric balloon system to treat obesity.
Intragastric balloon system
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 gastrectomy group
Operation way: sleeve gastrectomy
Using the sleeve gastrectomy to treat obesity.
Sleeve gastrectomy
Sleeve gastrectomy is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss.
Interventions
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Intragastric balloon system
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 gastrectomy
Sleeve gastrectomy is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss.
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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.
Exclusion Criteria
* 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;
* 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.
18 Years
65 Years
ALL
No
Sponsors
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The Third Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Shaihong Zhu, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Third Xiangya Hospital of Central South University
Locations
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Shaihong Zhu, M.D.
Role: primary
Other Identifiers
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XY3-IGBWLG001
Identifier Type: -
Identifier Source: org_study_id