Diabetes, Falls, and Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Co-existence of peripheral- and vestiubular neuropathy in people with diabetes
研究概览
简要总结
Comparing severity of diabetic peripheral neuropathy (small and large fibers including autonomic neuroapthy) to postural control and vestibular measurements
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women with minimum 40 years of age and maximum 70 years of age.
- •Diagnosis of T1D or T2D
- •Diagnosis of diabetes with at least one year prior to inclusion of the study
- •Signed the informed consent.
排除标准
- •Severe decreased liver function (Alanin amino-transaminase (ALAT)>250u/l, GammaGlutamyltransferase (GGT)>150u/l)
- •Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15mmol/L/1,73m2
- •Pregnancy or breast feeding
- •Active malignancy or terminal ill.
- •Current or previous alcohol- or drug abuse
- •Not being able to understand Danish written and/or verbally
- •Terms according to investigators judgement that makes subjects unsuitable to participate including lack of understanding or reduced physical ability.
- •Participating in other clinical studies
- •Maximum of 10 hours of weekly exercise.
结局指标
主要结局
Co-existence of peripheral- and vestiubular neuropathy in people with diabetes
时间窗: through study completion, an average of 2 years
Vestibular neuropathy (measured by pathological video head impulse test (v-Hit) (one-sided, two-sided or specific arcways)) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes.
Co-existence of peripheral neuropathy and impaired dynamic postural control in people with diabetes
时间窗: through study completion, an average of 2 years
Dynamic balance (measured by Bertec) will be compared with peripheral neuropathy (measured by quantitative sensory testing, nerve conduction and COMPASS-33) in the population with diabetes.
次要结局
- Correlation between the severity of peripheral neuropathy and the severity of vestibular in terms of degree of pathological video head impulse testingneuropathy(through study completion, an average of 2 years)
- The impact of peripheral neuropathy on postural control (In quite stance)(through study completion, an average of 2 years)
- Correlation between distal neuropathy and dynamic postural control (including patterns)(through study completion, an average of 2 years)
研究者
Nicklas Højgaard-hessellund Rasmussen
Postdoc and researcher
Aalborg University Hospital