The Effect of Exercise of High Vs. Moderate Intensity on the Brain in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Neurometabolite levels
研究概览
简要总结
The goal of this clinical trial is to learn if exercise training of high or moderate intensity is most optimal to improve brain health and prevent neurodegeneration in type 2 diabetes patients. The main question it aims to answer is:
What is the effect of exercise training of high vs. moderate intensity on brain metabolism, brain perfusion, and cognition in type 2 diabetes?
Researchers will compare the exercise training groups to a control group without exercise training to determine the effect of exercise training on the brain in type 2 diabetes.
Participants will exercise for 6 months, 3 times per week. Before and after these 6 months, they will undergo:
- a brain MRI scan
- cognitive tests
- blood sampling
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •no insulin therapy
- •30-75 years old
- •right handed
- •physically inactive
排除标准
- •left handed
- •MRI contraindications
- •psychological disorders
- •exogenous insulin therapy
- •history of coma, transient ischemic attack, head trauma, brain tumor, stroke, epilepsy, and other central nervous system diseases that could cause dementia or presence of dementia before T2DM
- •suffering from any disease with significant impact on exercise intervention participation such as: chronic heart disease (e.g. valve insufficiency ≥ grade 2) or significant arrhythmias, cardiac events less than one year ago (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), clinical heart failure (oedema, shortness of breath), percutaneous coronary intervention less than one year ago, chronic obstructive pulmonary disease (COPD), cerebrovascular or peripheral vascular disease
- •severe hypertension (>160/110 mmHg)
- •ongoing cancer, severe neuropathy (limiting exercise participation)
- •renal disease (GRF <45 ml/min/1,73 m2)
- •inability to regularly participate in the exercise intervention
- •pregnancy
- •breastfeeding
结局指标
主要结局
Neurometabolite levels
时间窗: From enrollment to the end of treatment at 6 months
Levels of N-acetylaspartate, choline, myo-inositol, creatine, glutathion, and glutamate, measured in institutional units (i.u.) by means of magnetic resonance spectroscopy (MRS).
Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI)
时间窗: From enrollment to the end of treatment at 6 months
Changes in cerebral perfusion expressed in mL/100g/min, and blood flow through the blood-brain-barrier expressed in milliseconds
次要结局
- Levels of neurodegenerative blood biomarkers(From enrollment to the end of treatment at 6 months)
- Blood lipid profile(From enrollment to the end of treatment at 6 months)
- Brain volume(From enrollment to the end of treatment at 6 months)
- Diffusion-weighted magnetic resonance imaging(From enrollment to the end of treatment at 6 months)
- Fasted blood glucose(From enrollment to the end of treatment at 6 months)
- Kidney function (eGFR)(From enrollment to the end of treatment at 6 months)
- Cognitive function: MoCA(From enrollment to the end of treatment at 6 months)
- Cognitive function: Face recognition test(From enrollment to the end of treatment at 6 months)
- Cognitive function: Object location test(From enrollment to the end of treatment at 6 months)
- Cognitive function: Trail making test(From enrollment to the end of treatment at 6 months)
- Cognitive function: Stroop colour and word test(From enrollment to the end of treatment at 6 months)
- Cognitive function: Rey auditory verbal learning test(From enrollment to the end of treatment at 6 months)
- Subjective cognitive function(From enrollment to the end of treatment at 6 months)
- Peak load during CPET(From enrollment to the end of treatment at 6 months)
- VO2peak during CPET(From enrollment to the end of treatment at 6 months)
- Fasted blood HbA1c(From enrollment to the end of treatment at 6 months)
- Fasting insulin(From enrollment to the end of treatment at 6 months)
- Kidney function (creatinine)(From enrollment to the end of treatment at 6 months)
研究者
Dominique Hansen
Full professor
Hasselt University