Metabolic Characterization of Subjects With Adipositas Before and After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Central insulin sensitivity
研究概览
简要总结
Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. So far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. It is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. One special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years
- •planned bariatric surgery (laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy)
- •stable medication 10 weeks before begin of the study
排除标准
- •persons who wear non-removable metal parts in or on the body.
- •persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
- •cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
- •persons with hearing impairment or increased sensitivity to loud noises
- •people with claustrophobia
- •minors or non-consenting subjects are also excluded
- •subjects with an operation less than 3 months
- •neurological and psychiatric disorders
- •subjects with hemoglobin Hb <11 g / dl
- •hypersensitivity to any of the substances used
结局指标
主要结局
Central insulin sensitivity
时间窗: Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.
Central insulin sensitivity will be assessed by fMRI after application of nasal insulin or placebo.
Peripheral insulin sensitivity
时间窗: Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.
Peripheral insulin sensitivity will be assessed by oral glucose tolerance test.
次要结局
- Whole body fat distribution(Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.)
- Liver fat content(Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.)
- Metabolic rate(Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.)
- Response to food cues(Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.)
- Trail-making test(Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.)
- Glucose tolerance(Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.)
- Weight loss(Weight loss before and 6 months after surgery.)
- Hopkins-verbal learning test(Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards.)
- Insulin secretion(Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.)