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study never started due to funding issues
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This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.
Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to help the participant loose weight along with healthy eating, diet and exercise. This study involves minimally invasive laparoscopic surgery to place the adjustable band around the upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball. One end of the band ends with a flat balloon that goes around the upper part of the stomach. The opening from this small stomach can be changed to allow more or less food into the intestine depending on the amount eaten and the amount of weight lost.
The other end of the of the band ends in a filling port through which saline solution is pumped with a needle through an attached tube to inflate or deflate the balloon. The filling port is attached to the wall of the abdomen under the skin. Because the flow of food is regulated by the band, most people feel full faster. This is how the appetite for food is controlled and the why the person is likely to eat less with the band in place.
Food is digested through the normal digestive process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Use of Realize gastric band (Ethicon) in adolescents for weight reduction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REALIZE Gastric band (ETHICON) | Device | Placement of gastric band around upper stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Reduction in percent of excess weight loss (%EWL). | Monthly up to one year |
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Inclusion Criteria:
BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5
Exclusion Criteria:
•Hypertension: Systolic blood pressure (SBP) of 140 mm Hg
fasting glucose
blood pressure
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| Name | Affiliation | Role |
|---|---|---|
| Sayeed Ikrammudin, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |