Study of Nerve Conduction Parameters in Subjects with Type-II Diabetes Mellitus-A Cross Sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Bilateral Median, Ulnar, Tibial, Peroneal, Sural, superficial peroneal, median sensory and Ulnar sensory nerves will be studied
研究概览
简要总结
This study is a cross-sectional study in which nerve conduction parameters of Bilateral Median, Ulnar, Tibial and common peroneal motor nerves; and Bilateral Median, Ulnar, Sural and Superficial peroneal sensory nerves will be recorded using RMS EMG SALUS software. Appropriate statistical test and software will be utilized for analysis.
The above parameters will then be correlated with Duration of diabetes, HbA1c levels and Body mass index values. Also, the parameters will be compared between males and females to determine any gender effect.
This study will behelpful to the society in terms of providing objective Diabetic Peripheral Neuropathy (DPN) measurements,analysis of various factors that could alter the disease process . Timelydiagnosis of DPN will definitely aid inprevention of it’s deadly complications. This would ultimately result inimproved quality of life and reduction in health costs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with Type-II Diabetes mellitus (as per WHO criteria) willing and capable of providing consent.
排除标准
- •Subjects with type-I Diabetes Chronic alcoholic cerebrovascular stroke peripheral neuropathy due to some other known cause peripheral arterial disease or evidence of limb ischemia subjects who refuse to give consent skin lesion or swelling which could interfere with Nerve conduction study trauma in the course of the nerve to be examined.
结局指标
主要结局
Bilateral Median, Ulnar, Tibial, Peroneal, Sural, superficial peroneal, median sensory and Ulnar sensory nerves will be studied
时间窗: One time study
nerve conduction parameters to be studied will include Compound motor action potential (CMAP) amplitude in millivolt
时间窗: One time study
Sensory nerve action potential (SNAP) amplitude in microvolts
时间窗: One time study
nerve conduction velocity (NCV) in metre/second
时间窗: One time study
次要结局
- correlation of Nerve conduction parameters with Duration of Diabetes, level of HbA1c, Body mass index.(Differences in nerve conduction parameters between Males and females)