Lifestyle Intervention in Patients With Diabetes Type 2 and the Association With the Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in insulin senistivity
研究概览
简要总结
To investigate whether targeted lifestyle intervention (exercise), induces a change in intestinal fecal microbiota related to improved glycemic control and systemic inflammation in patients with DM type 2.
详细描述
Diet and exercise are the most beneficial lifestyle interventions in patients with diabetes mellitus (DM) type 2, causing an increase in glucose tolerance.
One of the mechanisms through which these treatment modalities work might be explained through changes in the gut microbiota. Recent studies show that the chronic inflammatory status causing insulin resistance in DM type 2, is triggered by an increase in circulating bacterial lipopolysaccharide (LPS). Strict lifestyle intervention, such as exercise, so called Diabetes Bootcamp (DB), may manipulate the gut microbiota, reducing circulating LPS, causing an improvement of the insulin-mediated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subjects must meet the criteria for diabetes type 2 (a random blood sugar of > 11.1 mmol/L and/or a fasting blood sugar lever of >7.0 mmol/L and/or a blood sugar of >11.1 mmol/L two hours after an oral glucose tolerance test and/or an HbA1c level of >47 mmol/mol).
- •Male or female (post-menopausal)
- •Age above 45 years and below 70 years
- •BMI >30 kg/m2
- •HbA1c < 80 mmol/mol or < 8,6% Subjects must use metformin
- •Stable medication use
- •Stable tension regulation (with or without medication)
- •Subjects should be able to give informed consent
排除标准
- •A history of cardiovascular event (Cerebrovascular event, myocardial infarction or pacemaker implantation)
- •Severe-very severe lung emphysema (GOLD stage III-IV)
- •Use of any antibiotics or proton pump inhibitor (PPI) in the past three months
- •Use of any other antidiabetic medication besides metformin (e.g. SU-derivates, insulin)
- •Use of a platelet inhibitor or cumarin derivate during
- •Subjects participated in a lifestyle programme in the past 6 months (diet or exercise)
研究组 & 干预措施
Exercise program
Twice weekly exercise program, combined aerobic and strenght training
干预措施: Combined aerobic and strength exercise (Behavioral)
结局指标
主要结局
Change in insulin senistivity
时间窗: Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Rate of disappearance measured by the hyperinsulinemic-euglycemic clamp with stable glucose isotopes.
Change in capillary recruitment
时间窗: Before and after exercise, i.e. from first visit (0 weeks) untill last visit (13 weeks)
Insulin-induced capillary recruitment in skeletal muscle and heart
Changes in gut microbiota composition upon exercise
时间窗: At baseline, after 7 weeks, after 13 weeks
alfa-diversity, beta-diversity
次要结局
- Changes in resting energy expenditure(Before and after exercise)
- Changes in continous cardiovascular monitoring(Before and after exercise)
研究者
Erik Serne
Principal Investigator
Amsterdam UMC, location VUmc