FOOD ASPIRATION THERAPY ON OBESITY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 研究人群将包括总共10名肥胖受试者（BMI>=35<= 50 kg/m2），他们计划接受胃旁路手术作为肥胖治疗。 在进行全面的医学筛选和口服葡萄糖耐量试验（OGTT）后，受试者将入住GCRC 11天。 在入院第2天，受试者将在内镜下置入胃造口管。 在GCRC住院期间，受试者将自由进食常规饮食，每日补充多种维生素。 每日由GCRC生物营养学家记录饮食摄入量。 从第3天开始，每天早餐、午餐和晚餐后立即通过注射器抽吸排空约1000 cc胃内容物。 将口服等体积的口服补液溶液（含钠（105 mEq/L）、钾（20 mEq/L）、氯化物（120 mEq/L）和柠檬酸盐（10 mEq/L）），以替代吸出的胃内容物。 将每天监测血清电解质、BUN和肌酐浓度、体重和生命体征。 将在第2、3、4、6、8和10天评估血清镁、磷和钙。 根据体重和血清电解质浓度的变化，调整每天胃内容物的清除量。 目标体重减轻是第一周初始体重的2%，此后每周体重减轻1%。 根据临床评价，如有需要，将给予口服液和矿物质补充剂，或静脉输液和电解质。 在GCRC中，受试者将接受以下培训：1）评价其自身胃内容物。2)保持胃造口管部位清洁，3）识别胃造口管并发症的体征和症状，4）识别脱水的体征和症状，以及5）记录每日食物摄入和进食模式、食欲视觉模拟量表和排空的胃内容物体积。 出院后，受试者将在家中每天记录食物摄入量和饮食模式、食欲视觉模拟量表、排空的胃内容物体积和体重。 受试者将在每次主餐后继续排空胃内容物，每天3次。 研究护士将每周一次在家中呼叫受试者，持续24周，以审查医疗问题、体重减轻模式并讨论任何问题。 受试者将在第13天和第17天返回门诊GCRC，然后每周一次，直至24周研究结束。 每次访视时，研究医生或护士将检查受试者，记录体重，并采集血液用于电解质、BUN、肌酐、磷和镁。 将在基线和第4、12和14周采集用于CBC、LFT和NEFA的空腹血样。 将在基线、12周和24周时获得空腹血脂（甘油三酯、LDL-胆固醇、HDL-胆固醇）、胰岛素和瘦素。 此外，将在第24周更换OGTT，并在每减轻50磅体重后进行ECG检查。 在24周研究完成时，将移除胃造口术管，并向受试者提供饮食和行为调整指导，以帮助他们保持体重减轻。 此外，他们仍然可以选择进行减肥手术。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for 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.