A trial to determine the effects of reduced intra-abdominal pressure (IAP) on obesity Co-morbidity. Severe obesity has become an epidemic problem in the United States as well as world-wide, and is associated with a number of morbid conditions which produce enormous health-care costs and work disability. Some of the problems caused by obesity are intra-abdominal pressure, urinary bladder pressure, breathing problems, gastroesophageal reflux, high blood pressure, and possibly, type II diabetes. This study will determine if an external device, which can lower intra-abdominal pressure, can be safely used and if it will reverse the physical problems caused by obesity. Also, the study will determine if using the device while sleeping 1/3 to = of the day will lower the long-term intensity of these problems. Patients with the previous list of problems caused by obesity who are being evaluated for a gastric procedure to treat severe obesity will be asked to participate in this study. Patients will be admitted to the CRC. Baseline studies of blood pressure, blood and urine tests will be done on the first day of the visit. On the second day a catheter will be inserted into the bladder to measure pressure and to collect urine. Patients will be randomly assigned to the group using the external device (The ABSHELL), or to a control group or non-treatment group. This will determine if rest alone in a non-stressful environment is as effective as the use of the device. Those randomized to use the device will have it placed on the abdomen and a vacuum applied until the bladder pressure is decreased toward a level seen in non-obese individuals. The device will be worn continuously for the next four days and released only for meals and use of the bathroom. Blood will be obtained during the study. Blood pressure and pulse rate will be frequently measured during the use of the ABSHELL and the negative pressure reduced or released if severe discomfort or a marked fall in blood pressure develops. Non-invasive ultrasound will be used to measure some large blood vessels in the neck and leg and to measure their rate of blood flow. During the second week of the study, patients will be asked to wear the ABSHELL at night while sleeping. Based upon a previous pilot study, most patients feel more comfortable in the ABSHELL, feeling less bloated, breathing more easily, and sleeping more easily.
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