Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (SLIM Trial) - Part 3: Metabolic Mechanisms and Inflammatory Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in glucose tolerance
研究概览
简要总结
Investigation of underlying metabolic mechanisms and impact on the two surgical procedures on inflammatory factors.
详细描述
The aim of this project is to investigate underlying metabolic mechanisms in a subpopulation of patients of the SLIM trial, where a laparoscopic proximal Roux-en-Y gastric bypass (LRYGB) with a longer biliopancreatic limb (BPL) is compared to a standard LRYGB. For this purpose, the aim is to examine differences in number of intestinal enteroendocrine cells, subpopulations of intestinal macrophages, and gene expression or DNA-methylation in tissue samples obtained by colonoscopy from the ileum and transverse colon. In addition, gut microbiota (from colon biopsy and fecal samples), meal-stimulated gut hormone profiles, glycemic control, and metabolite patterns (metabolomics; in blood, urine, stool and breath) including plasma bile acid concentrations preoperatively and 6 months post-surgery will be examined. Body composition (fat mass and lean mass) will be measured by means of BIA (bioimpedance analysis; Biacorpus).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 x 25 patients with morbid obestiy (BMI of 35 kg/m2 or higher) who comply with the regulatory rules for bariatric surgery in Switzerland (SMOB guidelines) and participate in the SLIM Trial
- •15 healthy lean controls
排除标准
- •general contraindications to kind of surgery
- •known or suspected non-compliance
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
- •participation in another interventional study
- •BMI > 60 kg/m2
- •height < 145 cm
- •CL length of < 180 cm as measured intraoperatively
- •ASA physical status classification > III
- •inflammatory bowel disease
- •intake of corticosteroids, anti-inflammatory/ immunosuppressive drugs potentially altering immune cells
- •clinical signs of current infection
- •known anemia (e.g. hemoglobin < 110g/L for males, < 100g/L for females)
- •known neutropenia (e.g. leucocyte count < 1.5 x 10^9/L or ANC < 0.5 x 10^9/L)
- •known immunodeficiency, e.g. HIV
- •known vasculitis, collagenosis
- •known adrenal insufficiency and/or substitution with glucocorticoids
- •risky daily alcohol consumption (> 24g/d for males, > 12g/d for females)
- •drug abuse
- •known liver cirrhosis Child B or C
- •known uncontrolled congestive heart failure
- •known uncontrolled malignant disease
- •currently pregnant or breastfeeding
结局指标
主要结局
Change in glucose tolerance
时间窗: pre-OP and 6-8 months post-OP
Change in glucose tolerance as measured by plasma glucose concentrations at 120 minutes after ingestion of a standardized liquid test meal, pre-OP and 6-8 months post-OP.
次要结局
- gastrointestinal peptides(pre-OP and 6-8 months post-OP)
- intestinal enteroendocrine cells(pre-OP and 6-8 months post-OP)
- glycemic control(pre-OP and 6-8 months post-OP)
- intestinal macrophages(pre-OP and 6-8 months post-OP)
- gut microbiota composition(pre-OP and 6-8 months post-OP)
- appetite-related sensations(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 3(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 9(pre-OP and 6-8 months post-OP)
- intestinal glucose absorption rate(pre-OP and 6-8 months post-OP)
- bile acids(pre-OP and 6-8 months post-OP)
- inflammatory profile(pre-OP and 6-8 months post-OP)
- body composition(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 1(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 8(pre-OP and 6-8 months post-OP)
- mineral metabolism (urine) 2(pre-OP and 6-8 months post-OP)
- mineral metabolism (urine) 5(pre-OP and 6-8 months post-OP)
- enterocyte gene expression(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 2(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 5(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 12(pre-OP and 6-8 months post-OP)
- mineral metabolism (stool) 1(pre-OP and 6-8 months post-OP)
- mineral metabolism (stool) 2(pre-OP and 6-8 months post-OP)
- mineral metabolism (urine) 1(pre-OP and 6-8 months post-OP)
- mineral metabolism (urine) 3(pre-OP and 6-8 months post-OP)
- mineral metabolism (urine) 4(pre-OP and 6-8 months post-OP)
- immune response(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 10(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 11(pre-OP and 6-8 months post-OP)
- metabolomic patterns(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 4(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 6(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 7(pre-OP and 6-8 months post-OP)
- mineral metabolism (stool) 3(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 13(pre-OP and 6-8 months post-OP)
- mineral metabolism (blood) 14(pre-OP and 6-8 months post-OP)