Impact of the Bacterial Colonial Metabolism on Fecal Water Toxicity as Biomarkers of Future Colorectal Cancer Risk After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery
研究概览
简要总结
The purpose of this study is to investigate the impact of bariatric surgery on the gut health. Patients operated with Roux-en-Y gastric bypass or sleeve gastrectomy and obese patients who want too loose weight with a traditional weight-loss program, will be followed up for 1 year. In these patients, the investigators will measure toxicity parameters to understand better the health status of their colon after surgery. In a next phase, the measured toxicity will be linked with certain players that might cause this toxicity. Protein metabolites, formed from undigested protein by microbiota in the colon, are expected to be toxic agents for the colon. Therefore, the investigators will investigate the fate of ingested protein once the surgery patients are metabolically stabilized.
详细描述
To quantify protein assimilation after bariatric surgery, the investigators will perform in bariatric surgery patients (Roux-en- Y gastric bypass and Sleeve Gastrectomy) and in a control group a cross-sectional study with a single test day. On the test day, the study participants will consume a test meal that contains intrinsically labelled egg proteins and will take a capsule with 14C-glycocholic acid and a capsule with 3H-labelled polyethylene glycol. Participants will record a food diary 72h before and after the test day and during the test collect breath samples for 6h. Urine and stool will be collected respectively up to 24h and 72h after consumption of the test meal.
For the 1-year follow up study, the 3 patient groups (Roux-en-Y gastric bypass, Sleeve gastrectomy and control group with traditional weight loss therapy) will have 5 visits, a baseline visit and 4 visits after surgery or after starting traditional therapy. The time points after baseline include 2 weeks, 3 months, 6 months and 12 months. Each visit, a blood and stool sample will be collected, a 7-day food and stool diary will be registered and also weight loss will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery patients (toxicity and protein assimilation) : BMI > 40 kg/m² or > 35 kg/m² if combined with either obstructive sleep apnoea syndrome, high blood pressure not controllable with 3 different medications or type II diabetes, (3) exclusion of other underlying causes of obesity by an endocrinologist, (4) having tried to lose weight on a non-surgical way for at least 1 year without result and (5) a positive advice from a multidisciplinary team consisting of a surgeon, endocrinologist, psychologist and dietitian.
- •Obese control group in weight loss program (toxicity) : obese but otherwise healthy patients on a weight loss diet (BMI > 30 kg/m²) in the context of the weight-loss program organised at the Obesity Clinic of University Hospital Leuven.
- •Control group (protein assimilation) : normal weight (BMI 25-30 kg/m²) or overweight (BMI 25-30 kg/m²).
排除标准
- •Intake of antibiotics 1 months before the start of the study. Pre-and probiotics, laxatives and anti-diarrhea drugs 2 weeks before the start of the study.
- •Surgery patients and control group (toxicity) : Gastrointestinal disease or major abdominal surgery in the past (except from appendectomy and cholecystectomy).
- •Surgery patients and control group (protein assimilation) : Lung, liver, kidney and gastrointestinal disease or major abdominal surgery in the past (except from appendectomy, cholecystectomy and bariatric surgery). Vegan, vegetarian, lactose-or gluten-free diet. Pregnant or lactating women and subjects who participated in the last year in a study with irradiation exposure.
结局指标
主要结局
Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery
时间窗: Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery
Faecal water toxicity : measured with a cell viability test. Toxicity : expressed as the dilution of faecal water at which 50 percent of the cells survive.
Degree of protein assimilation 6-24 months after bariatric surgery
时间窗: 6-24 months after surgery
Protein digestion, malabsorption and fermentation : assessed with stable isotope technology. Digestion and malabsorption : expressed as percent of the administered isotope dose. Fermentation : expressed as percent of maximal dose of the fermentation product that can be formed.
次要结局
- Degree of fat malabsorption 6-24 months after bariatric surgery(6-24 months after surgery)
研究者
Kristin Verbeke
Full Professor at the Faculty of Medicine KU Leuven
KU Leuven