This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The study population will consist of a total of 10 obese subjects (BMI of >=35<=50kg/m2) who are planning to have gastric bypass surgery as a treatment for obesity. After a thorough medical screening and oral glucose tolerance test (OGTT), subjects will be admitted to the GCRC for 11 days. On day 2 of admission, subjects will have a gastrostomy tube placed endoscopically. During the GCRC admission, subjects will consume an ad libitum regular diet, supplemented with a daily multivitamin. Dietary intake will be recorded daily by the GCRC bionutritionists. Beginning on day 3, approximately 1000 cc of gastric contents will be evacuated by syringe aspiration immediately after consuming breakfast, lunch and dinner each day. An equal volume of an Oral Rehydration Solution, containing sodium (105 mEq/L), potassium (20 mEq/L), chloride (120 mEq/L), and citrate (10 mEq/L), will be given orally to replace aspirated gastric contents. Serum electrolytes, BUN, and creatinine concentrations, body weight and vital signs will be monitored daily. Serum magnesium, phosphorus, and calcium will be assessed on day 2,3,4,6,8, and 10. The volume of gastric contents removed each day will be adjusted based on changes in body weight and serum electrolyte concentration. The target weight loss is 2% of initial body weight in the first week, and 1% body weight loss/week, thereafter. Oral fluids and mineral supplements, or intravenous fluids and electrolytes, will be given if needed, based on clinical evaluation.While in the GCRC, subjects will be trained to: 1) to evaluate their own gastric contents. 2) to maintain a clean gastrostomy tube site, 3) recognize signs and symptoms of gastrostomy tube complications, 4) recognize signs and symptoms of dehydration, and 5) record daily food intake and eating patterns, appetite visual analogue scale, and volume of evacuated gastric contents. After discharge subjects will record food intake and eating patterns, appetite visual analogue scale, volume of evacuated gastric contents, and body weight daily at home. Subjects will continue to evacuate gastric contents after each main meal, 3 times/day. Subjects will be called at home once each week for 24 weeks by the study nurse to review medical issues, weight loss pattern, and discuss any problems. Subjects will return to the outpatient GCRC on days 13 and 17, then weekly until the end of the 24-wk study. At each visit, the study physician or nurse will examine subjects, body weight will be recorded, and blood will be obtained for electrolytes, BUN, creatinine, phosphorus, and magnesium. Fasting blood samples for CBC, LFT, and NEFA will be obtained at baseline and weeks 4,12, and 14. Fasting blood lipids (triglycerides, LDL-cholesterol, HDL-cholesterol), insulin, and leptin will be obtained at baseline, 12 weeks and 24 weeks. In addition the OGTT will be replaced at week 24, and an ECG will be obtained after each 50lbs of weight loss.At the completion of the 24-week study, the gastrostomy tube will be removed adn subjects will be given dietary and behavior modification instructions to help them maintain their weight loss. In addition, they will still have the option of pursing bariatric surgery.
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