跳至主要内容
临床试验/NCT01847937
NCT01847937已完成不适用

Magnetic Resonance Diagnostics of Diabetic Peripheral Neuropathy

Aarhus University Hospital5 个研究点 分布在 2 个国家目标入组 115 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
5
主要终点
Increase in magnetic resonance signal intensity of segmented nerves

研究概览

简要总结

This project aims to develop high field MR techniques to detect nerve lesions in diabetic patients. The MRI findings will be compared to results from conventional evaluations and nerve conduction studies to determine the validity as part of a clinical practice.

详细描述

Background

Diabetes mellitus is a very frequent disorder with an estimated prevalence of 275,000 patients in Denmark. Diabetic peripheral neuropathy (DPN) is a late complication which often remains undiagnosed, but may occur in up to 40% of diabetic patients. Advanced neuropathy may induce irreversible damages to the nervous tissue, and to avoid further damages, early diagnosis is important followed by optimal treatment of diabetes. DPN is a common complication due to long term diabetes in both type 1 and type 2.

Nerve conduction studies (NCS) is the gold standard method to diagnose DPN. However, the technique is time consuming and introduces discomfort to the patient and, furthermore, early nerve dysfunction may not be detected by NCS. Magnetic resonance imaging (MRI) (3 Tesla) of peripheral nerves is a new technique entitled Magnetic resonance neurography (MRN). In recent studies MRN has documented morphological changes in individual nerve fascicles. In T2-weighted images hyperintensity is present in proximal parts of nerves from neuropathic patients as compared to healthy nerves. This hyperintensity is believed to reflect early and more widespread lesions to the nerve fascicles that are not detected by NCS. This is pointing towards MRN to become an important tool in the management of patient with peripheral neuropathies.

Recent technical development such as diffusion weighted imaging (DWI) and diffusion tensor imaging (DTI) are currently being evaluated for imaging of the peripheral nerve system. DTI is expected to provide information about the physiology of the nerves and may reveal vascular congestion such as; blockade of axoplasmic flow, leading to abnormal proximal accumulation of endoneurial fluid; and distal Wallerian degeneration changes. Fiber tracking used on DTI is clinically implemented in some cases of stroke, tumours, neuropathy surgery, and functional brain MR imaging. Additionally, fiber tracking has been used on neuropathic patients with carpal tunnel syndrome, but has yet to be used in DPN as a measure of physiological function of the peripheral nerves.

Investigator, sponsor and trail setting Patients will be recruited at Department of Endocrinology and Internal Medicine from a cohort of more than 1000 well-characterized diabetic patients. The main investigator finished his masters as a biomedical engineer at the MR Centre at Aarhus University Hospital where he specialized in MR scanning techniques and has since been working with research combining diabetes, neuropathy, MR techniques and image processing. The studies will be conducted in collaboration between Siemens AG, Copenhagen, Department of Endocrinology and Internal Medicine, Department of Neurology, MR Centre at Aarhus University Hospital, Department of Endocrinology and Internal Medicine at Odense University Hospital and Department of Neuroradiology at Heidelberg University Hospital.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of type 1 diabetes, without neuropathy
  • Clinical diagnosis of type 2 diabetes, without neuropathy
  • Clinical diagnosis of type 1 diabetes, with neuropathy
  • Clinical diagnosis of type 2 diabetes, with neuropathy
  • Clinical diagnosis of hereditary axonal neuropathy
  • Clinical diagnosis of hereditary demyelinised neuropathy
  • Healthy controls who do not use prescription drugs and are of normal weight (BMI between 20 and 30).

排除标准

  • The second cause of the neuropathy.
  • Persons who are under
  • Inability to perform nerve conduction study or magnetic resonance imaging.
  • Patients with liver disease, hypothyroidism, current or past alcohol abuse, rheumatological diseases and vasculitis.
  • Silver Treatment, in diabetics with wounds.

结局指标

主要结局

Increase in magnetic resonance signal intensity of segmented nerves

时间窗: within the first 20 days (plus or minus 6 days) after initial MR scan

Magnetic resonance neurography signal intensities from the sciatic, peroneal, and sural nerve is increased in diabetic patients with peripheral neuropathy compared to healthy control subjects.

次要结局

  • Examination of magnetic resoance morphological differences according to neuropathy(within the first 20 days (plus or minus 6 days) after initial MR scan)
  • Determine diffusion weighted magnetic resonance values according to neuropathy(within the first 20 days (plus or minus 6 days) after initial MR scan)
  • Correlation of magnetic resoance signal intensity value and nerve conduction thresholds(within the first 20 days (plus or minus 6 days) after initial MR scan)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vaeggemose

Research Assistant

Aarhus University Hospital

研究点 (5)

Loading locations...

相似试验