跳至主要内容
临床试验/CTRI/2020/12/029630
CTRI/2020/12/029630尚未招募不适用

Prevalence Of Cardiac Autonomic Neuropathy In Patients With Diabetes And Diabetic Foot Complications

PGIMER1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2020年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
PGIMER
入组人数
246
试验地点
1
主要终点
Prevalence of Cardiac Autonomic Dysfunction in various spectrum of Diabetes Mellitus

研究概览

简要总结

Cardiac Autonomic Neuropathy is defined as dysfunction in autonomic nervous system which affects baseline heart rate , vasomotor responses , and leads to fluctuations in Blood pressure. Its presence has been associated with long standing Diabetes Mellitus in many previous studies. We have seen that many patients with long standing Diabetes and its complications like Charcot arthroneuropathy develop sudden cardiac death which was attributed to abnormalities in autonomic functions . So, we will divide our patients in 3 groups - one with Diabetes and its complications like Diabetic foot or Charcot foot , one with Diabetes and peripheral neuropathy, one with duration matched patients with Diabetes Mellitus having no complications . We will calculate prevalence of CAN( Cardiac Autonomic Neuropathy) in these groups.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • •ï‚·Patients diagnosed with Diabetes Mellitus as per ADA diagnostic criterion ï‚·Patients who are able to perform maneuvers like valsalva and hand grip.
  • •ï‚· Patients who are able to understand and provide an informed signed consent Patients who are willing to give informed consent to participate in the study.

排除标准

  • 未提供

结局指标

主要结局

Prevalence of Cardiac Autonomic Dysfunction in various spectrum of Diabetes Mellitus

时间窗: At baseline( meaning- at the time of recruitment of patient into trial, as it is a cross sectional study , not having serial evaluation / follow up of the patient)

次要结局

  • To compare prevalence of Cardiac Autonomic Dysfunction in three groups , i.e. patients having charcots or foot ulcer ,patients having peripheral neuropathy and patients with diabetes who are having none of above mentioned complications(At baseline)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital

研究点 (1)

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