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临床试验/NCT06187129
NCT06187129尚未招募不适用

Evaluation of Nerve Ultrasound in Detecting Clinical and Subclinical Peripheral Neuropathy in Children and Adolescent With Type 1 Diabetes Mellitus

Esraa Hosny Dahy0 个研究点目标入组 100 人开始时间: 2024年3月1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
入组人数
100
主要终点
cross sectional area of peripheral nerves using nerve ultrasound

研究概览

简要总结

Aim of study:

To evaluate accuracy of nerve ultrasound in detecting clinical and subclinical peripheral neuropathy in children and adolescents diagnosed with type 1 diabetes melitus .

详细描述

Introduction Type 1 diabetes (T1D) is a chronic disease with long-term vascular complications which include nephropathy, retinopathy, neuropathy, and macrovascular disease . In childhood and adolescence, early functional and structural vascular related abnormalities may be present a few years after the onset of the disease, so In this period intensive education and treatment may prevent or delay the onset and progression of complications.

Diabetic neuropathy (DN) is an important complication in patients with diabetes since it is related to mortality, morbidity, and a decrease in the quality of life ,as it is associated with neuropathic pain, foot ulceration, and subsequently gangrene and amputation.

Typical DPN is a chronic, nerve-length-dependent, distal symmetrical sensorimotor polyneuropathy (DSPN) and is considered as the most common form among diabetic neuropathies .

DPN can be classified into subclinical and clinical stages; based on history with sensory disturbances (possible); symptoms and/or signs of nerve dysfunction (probable); symptoms and/or signs plus abnormal gold standard test (confirmed); abnormal gold standard test (subclinical).

Subclinical neuropathy is defined as asymptomatic peripheral neuropathy, which is one of the common complications of patients with diabetes mellitus (DM). There is considerable uncertainty about the prevalence of diabetic peripheral neuropathy (DPN) in pediatric populations, which is probably due to the lack of large epidemiological studies performed on pediatric patients with DM, who often show few symptoms of neurological involvement.

研究设计

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

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1.Children and adolescents aged 8-17 y diagnosed as type 1 DM according to American diabetes association ( ADA) (17) .
  • 2.On multiple injection or insulin pump for at least 5 years or more. 3.Patients are free from acute complication like diabetes ketoacidosis (DKA), symptomatic hypoglycemia, or infection for at least one month before enrollment in the study.

排除标准

  • 1.Age less than 8 years or more than 17 years. 2.Diabetes other than T1DM . 3.Patients with known neuropathy of any other cause rather than diabetes. 4.Diabetic children with thyroid dysfunction ,coelic disease or anemia.

结局指标

主要结局

cross sectional area of peripheral nerves using nerve ultrasound

时间窗: baseline

To evaluate accuracy of nerve ultrasound in detecting clinical and subclinical peripheral neuropathy in children and adolescents diagnosed with type 1 diabetes melitus .

次要结局

未报告次要终点

研究者

发起方
Esraa Hosny Dahy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esraa Hosny Dahy

assistant lecturer

Assiut University

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