Effect of Number of Meals on Metabolism After Weight Loss Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Difference in GLP-1 levels before and after gastric bypass surgery
研究概览
简要总结
The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.
详细描述
The main goal is to study the effect of meal size and texture on incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.
Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •morbidly obese individuals, BMI above 35 and less than 50 kg/m2 who chose GBP as treatment for their obesity
- •Must be able to attend all study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
- •Individuals with or without Type 2 Diabetes Mellitus are eligible
排除标准
- •Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
- •Patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome.
- •Currently pregnant or nursing.
- •Known cardiovascular disease.
- •Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
- •Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
- •past history of severe food allergy
- •History of Type 1 Diabetes Mellitus
- •Individuals taking insulin, thiazolidinedione, exenatide, or DPP-IV inhibitors
研究组 & 干预措施
Solid Meal Study Group A
Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.
干预措施: Acetaminophen (Drug)
Solid Meal Study Group A
Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.
干预措施: Solid Meal (Other)
Solid Meal Study Group A
Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.
干预措施: Single, 600 kcal meal (Other)
Liquid Meal Study Group A
Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal
干预措施: Liquid Meal (Other)
Liquid Meal Study Group A
Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal
干预措施: Acetaminophen (Drug)
Liquid Meal Study Group A
Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal
干预措施: Single, 600 kcal meal (Other)
Solid Meal Study Group B
Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.
干预措施: Solid Meal (Other)
Solid Meal Study Group B
Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.
干预措施: Acetaminophen (Drug)
Solid Meal Study Group B
Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.
干预措施: Multiple, 200 kcal meals (Other)
Liquid Meal Study Group B
Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.
干预措施: Liquid Meal (Other)
Liquid Meal Study Group B
Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.
干预措施: Acetaminophen (Drug)
Liquid Meal Study Group B
Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.
干预措施: Multiple, 200 kcal meals (Other)
结局指标
主要结局
Difference in GLP-1 levels before and after gastric bypass surgery
时间窗: 12-15 months
Investigators will assess GLP-1 levels in subjects pre and post-GBP
Difference in glucose levels before and after gastric bypass surgery
时间窗: 12-15 months
Investigators will assess glucose in subjects pre and post-GBP
Difference in insulin levels before and after gastric bypass surgery
时间窗: 12-15 months
Investigators will assess insulin levels in subjects pre and post-GBP
次要结局
- Difference in GLP-1 levels in solid vs liquid meals(12-15 months)
- Difference in glucose levels in solid vs liquid meals(12-15 months)
- Difference in insulin levels in solid vs liquid meals(12-15 months)
研究者
Blandine Laferrere
Professor of Medicine, Columbia University
Columbia University