Effects of Intragastric Balloon Surgery and Sleeve Gastrectomy on Brain Function

NCT05127213 | Unknown

• 1 other identifier: XY3-IGBWLG001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Mean overall weight loss response rate

  (Weight loss / total weight before treatment × 100%≥5%) number of subjects / total number of subjects × 100%

  16 weeks after operation

Secondary Outcomes (7)

• Mean total weight loss percentage of subjects（%TWL）

  The 16th, 24th and 32nd weeks after operation

• Weight loss maintenance

  The 16th, 24th and 32nd weeks after operation

• Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire

  The 16th, 24th and 32nd weeks after operation

• Questionnaire

  Preoperative and postoperative weeks 16, 24 and 32

• Gastrointestinal hormone

  Preoperative and postoperative weeks 16, 24 and 32

Study Arms (2)

Intragastric balloon system group

EXPERIMENTAL

Operation way: intragastric balloon system Using the intragastric balloon system to treat obesity.

Procedure: Intragastric balloon system

Sleeve gastrectomy group

EXPERIMENTAL

Operation way: sleeve gastrectomy Using the sleeve gastrectomy to treat obesity.

Procedure: Sleeve gastrectomy

Interventions

Intragastric balloon system PROCEDURE

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

Intragastric balloon system group

Sleeve gastrectomy PROCEDURE

Sleeve gastrectomy is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss.

Sleeve gastrectomy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaihong Zhu, M.D.

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaihong Zhu, M.D.

CONTACT

+86 15974267868; zshcsu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 19, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

CN (1)