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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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 is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGMean overall weight loss response rate
(Weight loss / total weight before treatment × 100%≥5%) number of subjects / total number of subjects × 100%
Time frame: 16 weeks after operation
Mean total weight loss percentage of subjects(%TWL)
Weight loss / total weight before treatment × 100%
Time frame: The 16th, 24th and 32nd weeks after operation
Weight loss maintenance
Weight loss and maintenance of subjects
Time frame: 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
Time frame: 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)
Time frame: Preoperative and postoperative weeks 16, 24 and 32
Gastrointestinal hormone
Changes of gastrointestinal hormone(ghrelin,leptin,cholecystokinin,adiponectin) levels after operation
Time frame: Preoperative and postoperative weeks 16, 24 and 32
Brain function
Brain functional magnetic resonance imaging
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Time frame: Preoperative and postoperative weeks 16, 24 and 32
Correlation of fecal microbial profile with obesity
Analysis of fecal microbial profile using 16s rRNA sequencing
Time frame: Preoperative and postoperative weeks 16, 24 and 32