FOOD ASPIRATION THERAPY ON OBESITY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。研究人群将包括总共10名肥胖受试者(BMI=35&lt；=50 kg/m2)，他们计划接受胃分流手术治疗肥胖症。在经过彻底的体检和口服葡萄糖耐量测试(OGTT)后，受试者将被送往GCRC，为期11天。在入院的第二天，受试者将在内窥镜下放置胃造瘘管。在GCRC入院期间，受试者将食用随意的常规饮食，并每天补充多种维生素。GCRC的生物营养学家将每天记录饮食摄入量。从第三天开始，每天吃完早餐、午餐和晚餐后，大约1000毫升的胃内容物将通过注射器抽吸出来。口服等量的补液液，包括钠(105mEq/L)、钾(20mEq/L)、氯化物(120mEq/L)和柠檬酸盐(10mEq/L)，以代替吸入的胃内容物。每天将监测血清电解质、尿素氮和肌酐浓度、体重和生命体征。分别在第2、3、4、6、8、10天测定血清镁、磷和钙的含量。每天的胃内容物清除量将根据体重和血清电解质浓度的变化进行调整。第一周的目标减重是初始体重的2%，此后每周减重1%。根据临床评估，如果需要，将给予口服液和矿物质补充剂，或静脉输液和电解质。在GCRC期间，受试者将接受以下培训：1)评估自己的胃内容物。2)保持胃造瘘管部位清洁，3)识别胃造瘘管并发症的体征和症状，4)识别脱水的体征和症状，5)记录日常进食和进食方式、食欲视觉模拟评分和排空胃内容物体积。出院后，受试者每天在家中记录食物摄入量和进食方式、食欲视觉模拟评分、胃排空容量和体重。受试者将在每顿主餐后继续排空胃内容物，每天3次。研究护士将在24周内每周给受试者打电话一次，回顾医疗问题、减肥模式，并讨论任何问题。受试者将在第13天和第17天回到门诊GCRC，然后每周一次，直到24周研究结束。在每次访问时，研究医生或护士将检查受试者，记录体重，并采集血液中的电解质、尿素氮、肌酐、磷和镁。空腹采血检测CBC、LFT和NEFA。空腹血脂(甘油三酯、低密度脂蛋白-胆固醇、高密度脂蛋白-胆固醇)、胰岛素和瘦素分别在基线、12周和24周采集。此外，OGTT将在第24周更换，体重每减轻50磅后将获得一次心电图。在为期24周的研究结束时，胃造瘘管将被拆除，受试者将接受饮食和行为调整指导，以帮助他们保持减肥。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.