FOOD ASPIRATION THERAPY ON OBESITY

食物吸取疗法治疗肥胖

• 批准号: 7603325
• 负责人: CHRISTIAN D STONE
• 金额: $ 0.03万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603325
• 关键词: Admission activity; Aspirate substance; Behavior Therapy; Blood; Blood Urea Nitrogen; Blood specimen; Blood urea nitrogen measurement; Body Weight; Body Weight decreased; Calcium; Chloride Ion; Chlorides; Citrate; Citrates; Computer Retrieval of Information on Scientific Projects Database; Creatinine; Daily; Dehydration; Desire for food; Dietary intake; Eating; Electrocardiogram; Electrolytes; Fasting; Food; Funding; Gastrostomy; Grant; High Density Lipoprotein Cholesterol; Home environment; IV Fluid; Institution; Instruction; Insulin; LDL Cholesterol Lipoproteins; Leptin; Liquid substance; Magnesium; Medical; Minerals; Monitor; Multivitamin; Nurses; OGTT; Obesity; Oral; Outpatients; Pattern; Phosphorus; Physicians; Population Study; Potassium; Rehydration Solutions; Research; Research Personnel; Resources; Screening procedure; Serum; Signs and Symptoms; Site; Sodium; Source; Stomach; Syringes; Time; Training; Triglycerides; Tube; United States National Institutes of Health; Visit; Visual Analogue Pain Scale; Week; bariatric surgery; base; blood lipid; day; dietary supplements; obesity treatment; research clinical testing

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 研究人群将包括10名肥胖受试者（BMI> = 35 <= 50kg/m2），他们计划进行胃搭桥手术作为肥胖症的治疗。 在进行彻底的医疗筛查和口服葡萄糖耐量测试（OGTT）之后，受试者将被接受GCRC 11天。 在入院的第2天，受试者将在内镜下放置胃造口管。 在GCRC入院期间，受试者将食用随意的常规饮食，并补充每日多种维生素。 饮食摄入量将由GCRC Bionutirtrientists每天记录。 从第3天开始，每天食用早餐，午餐和晚餐后，将立即撤离大约1000 cc的胃内容物。 口服含量（105 meq/L），钾（20 meq/L），氯化物（120 mEq/L）和柠檬酸盐（10 meq/l）的口服补液溶液等量相等，以替代抽吸胃含量。 血清电解质，面包和肌酐浓度，体重和生命体征将每天受到监测。 血清镁，磷和钙将在第2,3,4,6,8天和10天进行评估。每天去除的胃含量的体积将根据体重和血清电解质浓度的变化进行调整。 目标体重减轻是第一周的初始体重的2％，此后每周体重减轻1％。 根据临床评估，将在需要时给出口服液体和矿物质补充剂，或静脉输液和电解质。 在GCRC中，将对受试者进行培训：1）评估自己的胃含量。 2）要维持干净的胃造口管部位，3）识别胃造口管并发症的体征和症状，4）识别脱水的迹象和症状，5）记录每日食物摄入和饮食模式，食欲的视觉模拟量表以及疏散胃含量的量。 出院后，受试者将记录食物摄入和饮食方式，食欲视觉模拟量表，疏散胃含量的体积和家庭体重在家中。 每次主餐3次，受试者将继续撤离胃含量。 研究护士每周将在家中每周一次召集一次受试者，以审查医疗问题，减肥模式并讨论任何问题。 受试者将在第13天和第17天返回门诊GCRC，然后每周至24周的研究结束。 每次访问时，研究医师或护士将检查受试者，体重将被记录，并且将获得电解质，BUN，肌酐，磷和镁的血液。 CBC，LFT和NEFA的空腹血液样本将在基线和第4,12周以及14个。禁食血脂（甘油三酸酯，LDL-胆固醇，HDL-胆固醇），胰岛素和瘦素将在底座，12周和24周时获得。 此外，将在第24周更换OGTT，每次减肥50磅后将获得ECG。 在完成24周研究时，将为ADN受试者删除胃造口管，将为饮食和行为修改指示提供帮助，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。