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临床试验/CTRI/2019/08/020983
CTRI/2019/08/020983尚未招募不适用

Understanding Autonomic Neuropathy in Type 2 Diabetes Mellitus – A Prospective Observational Study in Patients Attending Outpatient Clinics of Tertiary Care Hospitals

Kaustav Saha1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. Autonomic neuropathy tests

研究概览

简要总结

Diabetic autonomicneuropathy (DAN) is a serious and often underestimated complication of diabetes.Due to its ability to potentially affect any tract of autonomic nervous system,DAN is a systemic-wide disorder, which encompasses a large spectrum of organsand leads to significant increase in morbidity and mortality. Subclinical DANcan occur within a year of diagnosis in T2DM and within 2 years in T1DM, whilefirst symptoms may onset after years.The most common and studied manifestationof DAN is cardiovascular autonomic neuropathy (CAN), owing to itslife-threatening complications (arrhythmias, silent myocardial ischemia, andsudden death) and to its relation with other microangiopathic comorbidities.  Diabetic neuropathy isclassically defined as “the presence of symptoms and/or signs of peripheralnerve dysfunction in people with diabetes after the exclusion of other causesâ€. Sensory, motor, or autonomic nerves can be involved, oftencoexisting.The reported prevalence of DAN varies widely depending on the cohortstudied and the methods of assessment. In randomly selected cohorts ofasymptomatic individuals with diabetes, ∼20% had abnormal cardiovascular autonomic function. DAN frequently coexistswith other peripheral neuropathies and other diabetic complications, but DANmay be isolated, frequently preceding the detection of other complications. DANmay affect many organ systems throughout the body (e.g., gastrointestinal [GI],genitourinary, and cardiovascular). Major clinical manifestations of DANinclude resting tachycardia, exercise intolerance, orthostatic hypotension,constipation, gastroparesis, erectile dysfunction, sudomotor dysfunction,impaired neurovascular function, “brittle diabetes,†and hypoglycemic autonomicfailure.

However, studiesprobing autonomic neuropathy dysfunctions in diabetic patients in Indianscenario are scare. Addressing this dearth, the present prospectiveobservational study has been planned to understand autonomic neurodeficit in acohort of type 2 diabetes mellitus (T2DM) patients attending the outpatientdepartment of a tertiary care hospital.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult diabetic patients
  • Patients of either gender
  • Ambulatory patients
  • Willingness to participate by signing consent form.

排除标准

  • Not willing to participate in study.

结局指标

主要结局

1. Autonomic neuropathy tests

时间窗: 1. At Baseline | 2. 6 months | 3. 12 Months

2. Glycaemic Control in terms of HbA1C, FBG, PPPG

时间窗: 1. At Baseline | 2. 6 months | 3. 12 Months

3. Microvascular complications

时间窗: 1. At Baseline | 2. 6 months | 3. 12 Months

4. Macrovascular complications

时间窗: 1. At Baseline | 2. 6 months | 3. 12 Months

5. Medication adherence

时间窗: 1. At Baseline | 2. 6 months | 3. 12 Months

6. Lifestyle modifications

时间窗: 1. At Baseline | 2. 6 months | 3. 12 Months

次要结局

  • 1.Basic demographics(2. Comorbidities)

研究者

发起方
Kaustav Saha
申办方类型
Other [self]

研究点 (1)

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