Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intragastric balloon system group | Experimental | Operation way: intragastric balloon system Using the intragastric balloon system to treat obesity. |
|
| Sleeve gastrectomy group | Experimental | Operation way: sleeve gastrectomy Using the sleeve gastrectomy to treat obesity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean total weight loss percentage of subjects(%TWL) | Weight loss / total weight before treatment × 100% | The 16th, 24th and 32nd weeks after operation |
| Weight loss maintenance | Weight loss and maintenance of subjects |
Not provided
Inclusion Criteria:
18 ≤ age ≤ 65, regardless of gender;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaihong Zhu, M.D. | Contact | +86 15974267868 | zshcsu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaihong Zhu, M.D. | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sleeve gastrectomy | Procedure | Sleeve gastrectomy is the use of laparoscopy to cut out the greater curvature of the stomach, mainly for weight loss. |
|
| 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 | 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) | Preoperative and postoperative weeks 16, 24 and 32 |
| Gastrointestinal hormone | Changes of gastrointestinal hormone(ghrelin,leptin,cholecystokinin,adiponectin) levels after operation | Preoperative and postoperative weeks 16, 24 and 32 |
| Brain function | Brain functional magnetic resonance imaging | Preoperative and postoperative weeks 16, 24 and 32 |
| Correlation of fecal microbial profile with obesity | Analysis of fecal microbial profile using 16s rRNA sequencing | Preoperative and postoperative weeks 16, 24 and 32 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |