跳至主要内容
临床试验/NCT02931773
NCT02931773Unknown不适用

Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients and in Pre-Diabetes Patients

Instituto Nacional de Cardiologia Ignacio Chavez1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Sympathetic hyperactivity in recently diagnosed DM2 patients

研究概览

简要总结

The investigators are studying the initial autonomic alterations in participants recently diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation.

详细描述

Until now the autonomic dysfunction in Diabetes Mellitus type 2 (DM2)has been broadly studied in long term patients. Thus, clinical features as cardiac autonomic neuropathy (CAN) and the lack of the baroreceptor reflex were widely described in patients with a long standing Diabetes. However, there hasn´t been a description of the initial autonomic imbalance in both Pre-Diabetes and recently diagnosed DM2 patients. This is the goal of the present research study, to assess the autonomic dysfunction among these sets of patients.

Yet CAN is finding mostly happening in late stages of DM2 and so the lack of Baroreceptor reflex sensitivity there are other subtle indicators of dysautonomia which hasn't been extensively analyzed. In fact, rest tachycardia and orthostatic intolerance may point to an early dysautonomia. A description of the impairment of the cardiovascular autonomic regulation is still missing. Therefore, the investigators intend to evaluate this regulation through the means of a Task Force System.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke

排除标准

  • Those older than 55 years old, or younger than 18 years old.
  • Those who have suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity or Ischemic Stroke

结局指标

主要结局

Sympathetic hyperactivity in recently diagnosed DM2 patients

时间窗: one year

to show that there is a cardiovascular sympathetic hyperactivity by the time of the initial treatment

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Cardiologia Ignacio Chavez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel A Sierra Beltran

Clinical Researcher

Instituto Nacional de Cardiologia Ignacio Chavez

研究点 (1)

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