Non-Response to Exercise - Identification of Factors Contributing to Exercise Non-response.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- exercise response with respect to changes in insulin sensitivity from baseline to post-intervention measurement
研究概览
简要总结
The purpose of this prospective intervention study is to find biomarkers and underlying pathomechanisms for non-response of improvement in glucose metabolism to exercise.
An additional goal is to identify non-responders at an early stage, where prevention strategies (pharmacologically or by specific training) will be successful.
详细描述
At baseline and end of study, an intensive metabolic phenotyping including cerebral insulin sensitivity as well as tissue biopsies are performed in overweight untrained healthy participants at high risk for type 2 diabetes. During the study, an individual exercise training at 80% VO2max is performed for 9 weeks. Before and after the training intervention, acute tissue biopsies after a standardized bout of exercise are obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •at least one of the following risk factors for type 2 diabetes:
- •overweight (BMI>27 kg/m2)
- •impaired fasting glucose and/ or glucose tolerance
- •former gestational diabetes
- •family history for type 2 diabetes (first-degree relative)
- •sedentary participant (< 2 exercise bouts/week)
排除标准
- •any kind of metal in or on the body
- •thermosensory or heightened sensitivity to heating
- •heightened sensitivity to loud noise or diseases of the ear
- •claustrophobia
- •Diabetes mellitus
- •current pregnancy or breastfeeding
- •cardiovascular diseases
- •surgery, < 3 months ago
- •participation in other clinical trials
- •acute illness/infection, < 4 weeks ago
- •severe mental illness
- •hemoglobin, women < 11g/dl, men < 13g/dl
- •potentially incompliant subjects and/or inability to absolve the exercise training
- •glucose influencing drugs
- •continuous analgetic drugs
- •use of anticoagulants
结局指标
主要结局
exercise response with respect to changes in insulin sensitivity from baseline to post-intervention measurement
时间窗: 11 weeks
insulin sensitivity is measured before and after the training intervention by a 5-point-75g-OGTT and calculated by ISI Matsuda
次要结局
- role of visceral fat mass in determining the non-response of insulin sensitivity to exercise(11 weeks)
- differences in the adaptation process to exercise in responders versus non-responders(11 weeks)
- inflammatory response to exercise(11 weeks)
- molecular mechanisms of non-response(11 weeks)
- identification of serum biomarkers of non-response(11 weeks)
- changes in brain insulin sensitivity by exercise, and brain differences in responders vs. non-responders(11 weeks)
研究者
Dr. Anja Boehm
Dr. med. (MD)
University Hospital Tuebingen