Small Intestinal Ketogenesis - Potential Significance for Type 2 Diabetes in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Glucemia following a Mixed Meal Test:
研究概览
简要总结
The goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
详细描述
The investigators have recently shown that the mucosa in the middle small intestine, the jejunum, in human volunteers produce ketones bodies.This situation is thus contrary to the common view that ketone bodies are formed by the liver during fasting/starvation. Obesity is commonly associated with hyperglycaemic conditions and diabetes mellitus type 2.This has given rise to the question of whether obesity results in disturbances in the intestinal food-induced ketogenesis and whether this influence contributes to the development of type 2 diabetes mellitus?
The project's questions are therefore:
- Does food intake-induced ketogenesis exist in the small intestine of obese individuals?
- Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?
- If no to 2: What is the difference?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •BMI 35 to 45 kg/m2
排除标准
- •Insulin-treated diabetes
- •Sequelae of previous diabetes-associated disease (foot, eyes and kidneys, or cardiovascular incident, etc.)
- •Diabetes, hypertension, lipid disorder that has not been stabilized for at least 1 month by adequate pharmacological treatment
- •Continuous NSAID use
- •Preferably otherwise medication-free (exceptions can be made)
- •Not operated on in the abdomen (appendectomy excluded)
- •Previously known organic gastrointestinal disease, except for gastroesophageal reflux disease (GERD)
- •Pregnancy and breastfeeding
- •History of drug abuse or other circumstances deemed to jeopardize the patient's ability to participate in the research project
结局指标
主要结局
Glucemia following a Mixed Meal Test:
时间窗: On day 12 of the respective diet
The study participant arrives fasted and a venous catheter is placed in one arm for blood sampling. The research subject may eat a brunch for approximately 15 minutes (sandwich, juice, fried egg and sausage; 550-600kcal) and the p-glucose (mM) is checked at 120 min. The glucemia after the test meal will be compared in high-carbohydrate diet and high-fad diet (paired samples).
次要结局
- Enteroscopy: mucosal glucose-transport capacity(On day 14 of the respective diet)
- Enteroscopy: ketogenic activity in the small intestine(On day 14 of the respective diet)