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临床试验/NCT03495089
NCT03495089已完成不适用

Feasibility and Effectiveness of Electrochemical Dermal Conductance Measurement for the Screening of Diabetic Neuropathy in Primary Care.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina6 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
147
试验地点
6
主要终点
Presence of diabetic neuropathy diagnosed by EMG

研究概览

简要总结

Diabetes mellitus is the leading cause of polyneuropathy in the Western world. Diabetic neuropathy is a frequent complication of diabetes and may have great clinical transcendence due to pain and possible ulceration of the lower extremities. It is also a relevant cause of morbidity and mortality in patients with diabetes. Although the cause of polyneuropathy in patients with diabetes is only partially known, it has been associated with chronic hyperglycaemia suggesting the possible aetiopathogenic implication of advanced glycosylation end-products. The strategy of choice in the medical management of diabetic neuropathy is early detection since glycaemic control and the use of certain drugs may prevent or slow the development of this disease. Diabetic neuropathy most often presents with a dysfunction of unmyelinated C-fibers, manifested as an alteration of the sweat reflex of the eccrine glands. This dysfunction can now be demonstrated using a newly developed technology which measures dermal electrochemical conductivity. This noninvasive test is easy and cost-effective. The aim of the present study is to evaluate the feasibility and effectiveness of dermal electrochemical conductance measurement (quantitative expression of the sudomotor reflex) as a screening test for the diagnosis of diabetic neuropathy in patients in primary care.

详细描述

The prevalence of diabetes mellitus (DM) is very high in Spain, being nearly 14% according to oral glucose tolerance test (OGTT) results . The management of DM requires a significant consumption of healthcare resources, mainly in relation to the care of vascular complications. Among the late microvascular events which may develop in patients with DM, polyneuropathy (PN) is the most common and disabling, and is the leading cause of morbidity and mortality in these patients. Indeed, in Spain, the leading cause of neuropathy is DM, with its prevalence increasing with the presence of DM and other risk factors such as obesity.

PN is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with DM after the exclusion of other possible causes. The Toronto Panel Consensus on PN defined this disorder as "symmetrical, depending on large fibers, sensory-motor attributable to metabolic and micro vessel disorders, as a result of chronic hyperglycemia and other risk factors". In patients with PN, thin fibers (autonomic system - sweating) and thermal and tactile sensitivity are first affected, followed by the involvement of large fibers, presenting an altered vibrating sensation which eventually alters electromyography (EMG) patterns. Therefore, dysfunction of sweat reflex in small distal fibers is one of the earliest changes to be detected in these patients.

The most common clinical presentation of PN is distal symmetric polyneuropathy (DSPN), being predominantly sensory in 80% of cases. Pain is the most important symptom, being described as burning or flashing, lancinating, deep, and with frequent exacerbations during rest (4). Pain often affects the quality of life of these patients, and it is a frequent cause of depression and/or anxiety. Moreover, some patients may develop hypoesthesia, which may lead to severe foot lesions.

The prevalence of DSPN varies greatly according to the population, definition and detection method. The Rochester study, including more than 64,000 patients, reported the prevalence of PN to be between 66% and 59% for type1 DM and type 2 DM, respectively. The 3rd report of the Technical Study Group of Diabetes of the World Health Organization (WHO) described a prevalence of 40% (8), and 50% in patients with more than 25 years of DM evolution. Pirart et al. reported a prevalence ranging from 25 to 48% (7,10-17), while in Spain, Cabezas-Cerrato et al. published a figure of 24.1%. DSPN-related factors are: age, DM duration, metabolic control, male gender, acute myocardial infarction, hyperlipidemia (especially hypertriglyceridemia), smoking, and general cardiovascular risk factors . Puig et al. also included urinary albumin excretion as a risk factor of presenting DSPN.

The diagnosis of DSPN is commonly made based on signs and symptoms and usually includes the use of several questionnaires such as the Neuropathy Disability Score (NDS), the Neuropathy Symptoms Score (NSS) and the Michigan Neuropathy Instrument (MNI). These questionnaires are easy to perform and are reproducible, sensitive and adequate for use in a screening program. Additionally, It was included a short scale (UENS - Utah Early Neuropathy Scale) to screen early neuropathy . This sensitive, fast and practical test, has 5 items and their score ranges from 0 to 42 points.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

盲法说明

A neurologist will be blinded to previous test results and will perform neurographyc test including sensory conduction study of the median, ulnar and sural nerves, and motor conduction study of the deep peroneal nerve.

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with type 2 DM
  • patients with pre-diabetes
  • patients without glucose alterations
  • Three main diagnostic categories (normal, pre-diabetes and diabetes) were defined using the WHO criteria based on 2-h postload glucose [<7.8 (140 mg/dL), 7.8-11.0 mmol/L (140-200 mg/dL) and / or fasting plasma glucose (6.1-6.9 mmol/L; 110-126 mg/dL) and >11.1 mmol/L (>200 mg/dL), respectively.

排除标准

  • Type 1 DM
  • upper or lower limb amputation (except phalanges),
  • diagnosis of neuropathy not related to diabetes
  • neuropathy by entrapment
  • use of psychoactive substances
  • chronic alcoholism
  • malnutrition
  • treatment with beta-blockers
  • presence of terminal disease or life expectancy less than 3 years
  • Pregnancy will be ruled out in women (negative pregnancy test) and a possible history of gestational diabetes will also be taken into account.

结局指标

主要结局

Presence of diabetic neuropathy diagnosed by EMG

时间窗: Day 1

Presence of diabetic neuropathy diagnosed by electromyography

次要结局

  • Utah Early Neuropathy Scale(Day 1)
  • Neuropathy Disability Score(Day 1)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (6)

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