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This is a cohort study with the objective of describing during a 12-month follow-up, weight loss in obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second.
Intragastric balloon (IGB) implantation is a widely used technique to treat overweight subjects and those with mild obesity. The effectiveness of the air filled balloon (Heliosphere BAG®) in improving weight loss, reduction of BMI, percentage of body weight loss, percentage of excess weight loss and complications six months after placement is notable. Several methods are available for IGB placement and new techniques are being developed to reduce discomfort during and after the procedure. Thus, the use of an IGB as an effective method to avoid bariatric surgery is proposed. However, the precise protocol to balance complications and discomfort while maximizing weight loss is still to be established.
Our secondary objectives will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese individuals | Obese patients submitted to treatment using two consecutively air-filled IGB (Heliosphere® 600 cc and Heliosphere 720 cc) without any interval between the removal of the first and the placement of the second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air-filled Intragastric balloon | Device | Weight loss system that consists of an air balloon that occupies space in the stomach, thus reducing the gastric capacity and leaving less volume for food. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Subtraction of the Final body mass index (BMI ) after 12 months of IGB placement minus the initial BMI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of early explant | Rate of patients in which the balloon was extracted early | 12 months |
| Operative complications | Rate of complications during the placement of the balloon |
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Inclusion Criteria:
Exclusion Criteria:
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Obese or overweight individuals eligible for gastric balloon placement and with no contraindications for the procedure will be recruited from the Mario Covas Hospital and the Kaiser Day Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Grecco, MD | School of Medicine of ABC, Santo Andre/SP Brazil | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medice of ABC | Santo André | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Through endoscopy completion, an average of 2 hours |
| Change in blood pressure | Arterial blood pressure will be measured before and after IGB using an digital sphygmomanometer | 12 months |
| Changes Glycated hemoglobin (HbA1c) | Blood measurements of Glycated hemoglobin (HbAq1c) will be reported in International Federation of Clinical Chemistry and Laboratory Medicine Units | 12 months |
| Physical activity | Physical activity will be self-reported on a weekly basis | 12 months |
| Caloric intake | Caloric intake will be self-reported on a weekly basis | 12 months |
| Excess weight loss | Measure that relates the preoperative weight, the postoperative weight and ideal weight | 12 months |
| Posoperative complications | Rate of postoperative complications | Through posToperative period completion, an average of 72 hours after the termination of surgery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |