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临床试验/CTRI/2026/03/105259
CTRI/2026/03/105259尚未招募不适用

A Study of the correlation between Diabetic Peripheral Neuropathy and Cardiac Autonomic Neuropathy in patients with Type 2 Diabetes Mellitus

Dr Kuchkar Snehal Sanjay1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月15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

研究概览

简要总结

Type 2 Diabetes Mellitus is commonly associated with microvascular complications including diabetic peripheral neuropathy and cardiac autonomic neuropathy While peripheral neuropathy is frequently diagnosed based on clinical symptoms and examination cardiac autonomic neuropathy often remains subclinical and underdiagnosed despite its association with increased cardiovascular morbidity and mortality

Early detection of cardiac autonomic dysfunction in patients with diabetic peripheral neuropathy may help in identifying high risk individuals and preventing adverse cardiovascular outcomes However the correlation between diabetic peripheral neuropathy and cardiac autonomic neuropathy in patients with type 2 diabetes mellitus is not clearly established in the local population

This cross sectional observational study aims to assess the prevalence of cardiac autonomic neuropathy in patients with type 2 diabetes mellitus and to determine its correlation with diabetic peripheral neuropathy Peripheral neuropathy will be assessed using validated clinical scoring systems and cardiac autonomic function will be evaluated using standard autonomic function tests The findings of this study may help in early identification of patients at risk and guide timely intervention

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients aged more than 30 years diagnosed with type 2 diabetes mellitus according to ADA criteria Duration of diabetes equal to or more than 5 years Availability of recent baseline labs within 3 months including HbA1c and serum creatinine Patients who provide written informed consent to participate in the study Patients who are able to undergo detailed neurological and cardiac autonomic function assessments.

排除标准

  • Patients with type 1 diabetes mellitus History of coronary artery disease congestive heart failure or significant valvular heart disease Known neurological disorders unrelated to diabetes eg stroke multiple sclerosis Parkinsons disease Patients with severe renal impairment eg eGFR less than 30 mLmin1.73 m² Patients with severe hepatic dysfunction Presence of chronic alcohol use which can cause independent neuropathy Patients on medications known to affect autonomic function eg beta blockers certain antidepressants Active malignancy or current chemotherapy known to cause neuropathy eg platinum agents taxanes vinca alkaloids within the past 6 to 12 months Known hereditary neuropathy eg Charcot Marie Tooth or family history suggesting inherited neuropathy.
  • Patients with history of chronic occupational or toxic exposure known to cause peripheral neuropathy eg heavy metals such as lead arsenic mercury Patients with Vitamin B12 deficiency Pregnant females.

研究者

发起方
Dr Kuchkar Snehal Sanjay
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kuchkar Snehal Sanjay

Vinayaka Missions Kirupananda Variyar Medical College and Hospital

研究点 (1)

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